Transcatheter deployment systems and associated methods

ABSTRACT

Various examples relate to a transcatheter delivery system including a sheath, a delivery catheter, and an implantable device (e.g., a prosthetic valve, a stent, a stent graft, occluder, or vascular filter) maintained in a collapsed configuration by the delivery catheter. The delivery catheter includes a plurality of fiber guides separated by one or more reduced profile sections each having a smaller transverse outer profile than the transverse outer profiles of the fiber guides.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/129,657, filed Sep. 12, 2018, now U.S. Pat. No. 10,987,218, issuedApr. 27, 2021, which claims the benefit of U.S. Provisional ApplicationNo. 62/579,756 filed Oct. 31, 2017, U.S. Provisional Application No.62/579,762, filed Oct. 31, 2017, and U.S. Provisional Application No.62/682,692, filed Jun. 8, 2018, all of which are incorporated herein byreference in their entireties for all purposes.

BACKGROUND

Depending on device design and the delivery system used, implantabledevices, such as prosthetic valves, are deliverable to a treatment siteusing a variety of methods. As one example, U.S. Pat. No. 9,629,718 toGloss et al., issued Apr. 25, 2017, is directed to a system thatincludes a prosthetic valve having a self-expanding frame and a holderconfigured to retain the frame of the prosthetic valve in a constrictedconfiguration and to control expansion of the frame. According to Glosset al., the holder has a controllably constrictable and expandable loop,wherein the loop is disposed about at least a portion of theself-expanding frame such that constriction or expansion of the firstloop controls constriction or expansion of the frame.

Advances over existing and contemplated transcatheter delivery systemsin the pertinent field remain to be realized.

SUMMARY

Various examples relate to a transcatheter delivery system including asheath, a delivery catheter, and an implantable device (e.g., aprosthetic valve, a stent, a stent graft, occluder, or vascular filter)maintained in a collapsed configuration by the delivery catheter. Thedelivery catheter includes a plurality of fiber guides separated by oneor more reduced profile sections each having a smaller transverse outerprofile than the transverse outer profiles of the fiber guides.

According to one example (“Example 1”), a transcatheter delivery systemincludes a delivery catheter for use with an implantable device. Thedelivery catheter includes a body portion, a support portion extendingfrom the body portion, a proximal constraint and a distal constraint.The support portion has a longitudinal axis and includes a proximalguide having a constraint passage and a transverse outer profile and adistal guide having a constraint passage, and, optionally a stake memberpassage, and the distal guide defining a transverse outer profile. Thedelivery catheter also has a first reduced profile section locatedintermediate the proximal guide and the distal guide, the first reducedsection having a smaller transverse outer profile than the transverseouter profile of the proximal guide and the transverse outer profile ofthe distal guide. The proximal constraint extends longitudinally fromthe body portion through the constraint passage of the proximal guideand radially from the constraint passage of the proximal guide. Theproximal constraint is secured in a releasable, looped configuration todefine a proximal constraining loop. The distal constraint extendslongitudinally from the body portion through the constraint passage ofthe distal guide and radially from the constraint passage of the distalguide. The distal constraint is secured in a releasable, loopedconfiguration to define a distal constraining loop.

According to another example (“Example 2”) further to Example 1, theconstraint passage of the proximal guide is at an angular positionrelative to the longitudinal axis of the support portion and theconstraint passage of the distal guide is at an angular positionrelative to the longitudinal axis of the support portion that isdifferent than the angular position of the constraint passage of theproximal guide.

According to another example (“Example 3”) further to Examples 1 or 2,the transverse outer profile of the first reduced profile section is atleast 10% smaller than the transverse outer profile of the proximalguide and the transverse outer profile of the distal guide.

According to another example (“Example 4”) further to any of Examples 1to 3, the transverse outer profile of the first reduced profile sectionis at least 20% smaller than the transverse outer profile of theproximal guide and the transverse outer profile of the distal guide.

According to another example (“Example 5”) further to any of Examples 1to 4, the transverse outer profile of the first reduced profile sectionis at least 50% smaller than the transverse outer profile of theproximal guide and the transverse outer profile of the distal guide.

According to another example (“Example 6”) further to any of Examples 1to 5, the support portion further includes an intermediate guide havinga transverse outer profile and a constraint passage, the intermediateguide being longitudinally-spaced from the proximal guide and the distalguide and being located intermediate the proximal guide and the distalguide, the constraint passage of the intermediate guide being at anangular position relative to the longitudinal axis of the supportportion. The support portion further includes a second reduced profilesection extending between the distal guide and the intermediate guide,the second reduced profile section having a smaller transverse outerprofile than the transverse outer profile of the distal guide and thetransverse outer profile of the intermediate guide, wherein the firstreduced profile section is located between the proximal guide and theintermediate guide. And, the transcatheter delivery system furthercomprises an intermediate constraint extending longitudinally from thebody portion through the constraint passage of the intermediate guideand radially from the constraint passage of the intermediate guide, theintermediate constraint secured in a releasable, looped configuration todefine an intermediate constraining loop.

According to another example, (“Example 7”), further to any of Examples1 to 6, the transverse outer profile of the second reduced profilesection is at least 50% smaller than the transverse outer profile of thedistal guide and the transverse outer profile of the intermediate guide.

According to another example, (“Example 8”), further to any of Examples1 to 7, the angular position of the constraint passage of the proximalguide is angularly offset from the angular position of the constraintpassage of the distal guide by 10 to 350 degrees.

According to another example (“Example 9”), further to any of Examples 6to 8, the angular position of the constraint passage of the intermediateguide is angularly offset from the angular position of the constraintpassage of the distal guide by 10 to 350 degrees.

According to another example (“Example 10”), further to any of Examples6 to 9, the intermediate guide defines a transverse outer profile thatis at least 50% smaller than the transverse outer profile of proximalguide and the transverse outer profile of the distal guide.

According to another example (“Example 11”), further to any of Examples1 to 10, the transcatheter delivery system further includes a stakemember releasably securing at least one of the proximal constraint inthe releasable, looped configuration and the distal constraint in thereleasable, looped configuration such that the stake member is operableto release at least one of the proximal and distal constraining loops.

According to another example (“Example 12”), further to any of Examples1 to 11, the transcatheter delivery system further includes a tipportion having a distal nose section and a proximal support section, theproximal support section having a reduced transverse outer profile thatdefines a recess configured to receive and support an end portion of aprosthetic valve in a compressed, delivery state; and/or the proximalguide is a support guide that has a stepped distal end that defines asupport surface for receiving an end portion of the prosthetic valve inthe compressed, delivery state.

According to another example (“Example 13”), further to any of Examples1 to 12, the transcatheter delivery system further includes a prostheticvalve maintained in a compacted delivery configuration by the proximalconstraining loop and the distal constraining loop, the prosthetic valveincluding a frame portion that is expandable and a leaflet constructsupported by the frame portion to define a leaflet region of theprosthetic valve, and further wherein the leaflet region is positionedon the support portion between the proximal guide and the distal guide.

According to another example (“Example 14”) further to Example 13, theleaflet region does not extend beyond the proximal guide and the distalguide.

According to another example (“Example 15”) further to Example 13 orExample 14, the distal guide is tapered proximally in transverse outerprofile for receiving a distal end of the leaflet region.

According to another example (“Example 16”) further to any of Examples13 to 15, the frame portion of the prosthetic valve has a distal end anda proximal end and includes a plurality of rows of frame membersdefining an undulating pattern of alternating distal-facing apices andproximal-facing apices, the plurality of rows of frame members includinga distal row at the distal end of the frame portion and a proximal rowat the proximal end of the frame portion, and further wherein the distalconstraining loop circumscribes the distal row at a position proximal tothe distal-facing apices of the distal row and the proximal constrainingloop circumscribes the proximal row at a position distal to theproximal-facing apices of the proximal row.

According to another example (“Example 17”) further to any of Examples13 to 16, the frame portion of the prosthetic valve has a distal end anda proximal end and includes a plurality of rows of closed cells definedby a plurality of frame members, each of the plurality of rows having adistal end, a proximal end, and a mid-portion between the proximal anddistal ends, the plurality of rows of closed cells including a distalrow of closed cells at the distal end of the frame portion and aproximal row of closed cells at the proximal end of the frame portion,and further wherein the distal constraining loop circumscribes thedistal row of closed cells at the mid-portion of the distal row ofclosed cells and the proximal constraining loop circumscribes theproximal row of closed cells at the mid-portion of the proximal row ofclosed cells.

According to another example (“Example 18”) further to any of Examples13 to 17, the frame portion of the prosthetic valve has a distal end anda proximal end and further wherein the distal constraining loopconstrains the distal end of the frame portion in a taperedconfiguration such that the frame portion defines a reduced transverseouter profile at the distal end of the frame portion and the proximalconstraining loop constrains the proximal end of the frame portion in atapered configuration such that the proximal end of the frame portiondefines a reduced transverse outer profile at the proximal end of theframe portion.

According to another example (“Example 19”) further to any of Examples 1to 18, the proximal guide has a second constraint passage and the distalconstraint passes through the second constraint passage of the proximalguide.

According to another example (“Example 20”) further to any of Examples 1to 19, the proximal guide has an angled portion.

According to another example (“Example 21”), a method of delivery animplantable medical device to a desired treatment site in a body of apatient with the transcatheter delivery system of any of precedingExamples 1 to 20, includes positioning the implantable medical device ata desired location in a patient using the transcatheter delivery system,the implantable medical device being mounted on the support portion ofthe transcatheter delivery system and maintained in a collapsed,delivery configuration by the proximal constraining loop and the distalconstraining loop of the prosthetic delivery system; releasing theproximal constraining loop by decreasing tension on the proximalconstraint such that a proximal portion of the implantable medicaldevice self-expands; and releasing the distal constraining loop bydecreasing tension on the distal constraint such that a distal portionof the implantable medical device self-expands.

According to another example (“Example 22”) further to Example 21, theproximal and distal constraining loops are released concurrently.

According to another example (“Example 23”) further to Example 21, theproximal and distal constraining loops are released sequentially.

According to another example (“Example 24”), a method of assembling atranscatheter delivery system includes arranging a prosthetic valve onthe support portion of the delivery catheter of any one of Examples 1 to20 such that a central longitudinal axis of the prosthetic valve islaterally offset from a central longitudinal axis of the support portionand a leaflet region of the prosthetic valve is located between theproximal guide and the distal guide of the support portion; compactingthe prosthetic valve into a radially compressed delivery configurationsuch that the leaflet region is received in securing the proximalconstraint and the distal constraint around the prosthetic valve and tothe delivery catheter with the stake member; and constraining theprosthetic valve in the radially compressed delivery configuration withthe proximal constraining loop defined by the proximal constraint andthe distal constraining loop defined by the distal constraint.

According to one example (“Example 25”), a transcatheter delivery systemincludes a delivery catheter. The delivery catheter includes a bodyportion, a support portion extending from the body portion, the supportportion configured to support an implantable device, a stake member, atleast one constraint configured to be tensioned to the stake member tomaintain the implantable device in a compacted delivery configuration,de-tensioned from the stake member to permit the implantable device tobe transitioned to an expanded deployed configuration, and to bereleased from the stake member to release the implantable device fromthe delivery catheter, and an actuation portion configured to tensionthe at least one constraint, de-tension the at least one constraint, andrelease the at least one constraint from the stake member. The actuationportion includes a housing assembly coupled to the body portion, a rackassembly received in the housing assembly and including a slide railsecured to the stake member and slidably receiving a slider secured tothe at least one constraint, a drive assembly slidably received over theslide rail and engageable with the slider to longitudinally translatethe slider within the slide rail, and an actuation assembly including arotatable deployment knob and configured to longitudinally translate thedrive assembly along the slide rail.

According to another example (“Example 26”) further to Example 25, theactuation portion further comprises a release assembly configured tolongitudinally translate the slide rail to longitudinally translate thestake member.

According to another example (“Example 27”) further to Examples 25 or26, the at least one constraint includes a catch releasably secured tothe stake member.

According to another example (“Example 28”) further to any one ofExamples 25 to 27, the drive assembly includes a clutch.

According to another example (“Example 29”) further to Example 28, theclutch is a ratchet clutch.

According to another example (“Example 30”) further to any one ofExamples 25 to 29, the body portion, the rack assembly, and the driveassembly are releasably secured to the housing assembly by one or moreclips, such that the rack assembly and the drive assembly are configuredto be released from the drive assembly and the housing and slidlongitudinally out from a distal end of the housing assembly.

According to another example (“Example 31”) further to any one ofExamples 25 to 30, the transcatheter delivery system comprises animplantable device maintained in a compacted delivery configuration onthe support portion by the at least one constraint.

According to another example (“Example 32”) further to Example 31, theimplantable device is a prosthetic valve.

According to another example (“Example 33”) further to any one ofExamples 25 to 32, the delivery catheter includes at least twoconstraints, each constraint configured to be tensioned to the stakemember to maintain the implantable device in the compacted deliveryconfiguration, de-tensioned from the stake member to permit theimplantable device to be transitioned to the expanded deployedconfiguration, and to be released from the stake member to release theimplantable device from the delivery catheter.

According to another example (“Example 34”) further to any one ofExamples 25 to 33, the actuation assembly further includes a nut portionand a gear portion defining a clutch arrangement such that rotation ofthe gear portion results in rotation of the nut portion up until atorsional limit is reached at which point the gear portion is allowed toslip against the nut portion.

According to another example (“Example 35”) further to Example 34, thenut portion is threaded onto the drive assembly.

According to another example (“Example 36”) further to any one ofExamples 34 or 35, the gear portion includes a plurality of teethengaged with a plurality of teeth of the deployment knob.

According to another example (“Example 37”) further to any one ofExamples 1 to 25, the delivery catheter further includes a stake memberand an actuation portion configured to tension at least one of thedistal and the proximal constraints, de-tension the at least one of thedistal and the proximal constraints, and release the at least one of thedistal and the proximal constraints from the stake member. The actuationportion includes a housing assembly coupled to the body portion, a rackassembly received in the housing assembly and including a slide railsecured to the stake member and slidably receiving a slider secured tothe at least one of the distal and the proximal constraints, a driveassembly slidably received over the slide rail and engageable with theslider to longitudinally translate the slider within the slide rail, andan actuation assembly including a rotatable deployment knob andconfigured to longitudinally translate the drive assembly along theslide rail.

According to another example (“Example 38”), the features of any one ofExamples 25 to 36 are further included with the features of Example 37.

According to another example (“Example 39”), further to any precedingexample, the implantable device includes a frame portion having aplurality of circumferentially-oriented eyelets configured to receiveone or more constraints.

According to another example (“Example 40”), further to any precedingexample, the transcatheter delivery system includes one or moreconstraints formed with an eye splice to define a catch.

According to another example (“Example 41”), further to any one ofExamples 2 to 6, the distal guide includes a filament that extendsaround the support portion to form a first securing loop that couplesthe distal guide to the support portion and a first guide loop thatdefines the constraint passage of the distal guide.

According to another example (“Example 42”), further to any one ofExamples 2 to 6 and 41, the proximal guide includes a filament thatextends around the support portion to form a first securing loop thatcouples the proximal guide to the support portion and a first guide loopthat defines the constraint passage of the proximal guide.

According to another example (“Example 43”), further to any one ofExamples 42, the filament of the proximal guide extends around thesupport portion to form a second securing loop that couples the proximalguide to the support portion, and further wherein the first guide loopof the proximal guide is located between the first securing loop and thesecond securing loop of the proximal guide.

According to another example (“Example 44”), further to any one ofExamples 42 or 43, wherein the filament of the proximal guide is formedinto a second guide loop that defines a passage, the second guide loopbeing located adjacent to the first guide loop of the proximal guide.

According to another example (“Example 45”), further to Examples 44, theconstraint passage of the first guide loop of the proximal guide isangularly offset from the passage of the second guide loop of theproximal guide.

According to another example (“Example 46”), further to any one ofExamples 2 to 6 and 41, the proximal guide includes a fiber guide tubethat defines the constraint passage of the proximal guide and whichincludes a receiving portion and a take-off portion, the receivingportion extending along the outer surface of the support portion at afirst, transverse angular position relative to a top of the supportportion and at a first longitudinal angle relative to the longitudinalaxis the support portion, and the take-off portion extending along theouter surface of the support portion at a second transverse angularposition relative to the top of the support portion that is differentthan the first, transverse angular position and at a second longitudinalangle relative to the longitudinal axis of the support portion that isdifferent than the first longitudinal angle.

According to another example (“Example 47”), further to Example 46, thefirst longitudinal angle is from −15 to 15 degrees.

According to another example, (“Example 48”), further to Examples 46 or47, the second longitudinal angle is from 75 to 105 degrees.

According to another example, (“Example 49”), further to any one ofExamples 46 to 48, the first transverse angular position is from 165 to195 degrees.

According to another example (“Example 50”), further to any one ofExamples 46 to 49, the second transverse angular position is from 120 to150 degrees.

According to another example (“Example 51”), further to any one ofExamples 46 to 50, the fiber guide tube further defines a transitionportion between the receiving portion and the take-off portion, thetransition portion extending longitudinally and circumferentially tocurve along the surface of the support portion.

According to another example (“Example 52”), further to any one ofExamples 46 to 51, the take-off portion defines an outwardly flaredoutlet of the fiber guide tube.

According to another example (“Example 53”), further to any one ofExamples 46 to 52, the receiving portion defines an outwardly flaredinlet of the fiber guide tube.

According to another example (“Example 54”), further to any one ofExamples 46 to 53, the proximal guide further includes a stake guidetube extending along the outer surface of the support portion at a thirdtransverse angular position relative to a top of the support portion andat a third longitudinal angle relative to the longitudinal axis of thesupport portion.

According to another example (“Example 55”), further to Example 54, thethird transverse angular position is from −15 to 15 degrees and thethird longitudinal angle is from −15 to 15 degrees.

According to another example (“Example 56”), further to any one ofExamples 2 to 6 and 41 to 55, the distal guide includes a fiber guidetube that defines the constraint passage of the distal guide and whichincludes a receiving portion and a take-off portion, the receivingportion of the distal guide extending along the outer surface of thesupport portion at a first transverse angular position relative to a topof the support portion and at a first longitudinal angle relative to thelongitudinal axis the support portion, and the take-off portion of thedistal guide extending along the outer surface of the support portion ata second transverse angular position relative to the top of the supportportion that is different than the first transverse angular position andat a second longitudinal angle relative to the longitudinal axis of thesupport portion that is different than the first longitudinal angle.

According to another example (“Example 57”), further to any precedingexample, the transcatheter delivery system includes a delivery catheterand an implantable device, such as a prosthetic valve, where theimplantable device includes at least one row of: a plurality ofconstraint guides included with a cover of the implantable device, aplurality of constraint retainers attached to a frame member of theimplantable device, or a plurality of apertures in a cover of theimplantable device for receiving a constraint of the transcatheterdelivery system to secure the implantable device in a compacted deliverystate.

According to another example, (“Example 58”), a transcatheter deliverysystem for a prosthetic valve includes a support portion configured tosupport a first frame and a second frame situated in series such thatthe first frame and the second frame are longitudinally offset from oneanother. The delivery system further includes a plurality of stakemembers including a first stake member and second stake member. Thedelivery system further includes a first constraint disposed about thefirst frame and operable to maintain the first frame in a deliveryconfiguration, wherein the first constraint is releasably engaged withthe first stake member. The delivery system further includes a secondconstraint disposed about the second frame and operable to maintain thesecond frame in a delivery configuration, wherein the second constraintis releasably engaged with the second stake member, and wherein thefirst and second stake members are operable to independent release thefirst and second constraints.

According to another example, (“Example 59”) further to Example 58, thedelivery system further includes a plurality of guides including a firstguide and a second guide, wherein the first constraint extends throughthe first guide and the second constraint extends through the secondguide.

According to another example, (“Example 60”) further to Example 59, thefirst stake member extends through the first guide.

According to another example, (“Example 61”) further to any of Examples58 and 59, the outer frame is supported at least, at least in part, bythe first guide, and wherein the inner frame is supported, at least inpart, by the second guide.

According to another example, (“Example 62”) further to any of thepreceding Examples, the first frame and the second frame arelongitudinally offset from one another such that a proximal end of theinner frame is situated distal of a distal end of the outer frame.

According to another example, (“Example 63”) a method of delivering aprosthetic valve, includes providing a prosthetic valve that includes anouter frame, and an inner frame nestable within the outer frame. Themethod further includes providing a transcatheter delivery system thatincludes a first constraint and a second constraint, and a first stakemember secured to the first constraint and a second stake member securedto the second constraint, wherein the prosthetic valve is loaded on thedelivery system such that the inner frame and the outer frame arelongitudinally offset from one another. The method further includesreleasing the first constraint from the first stake member such that theouter frame expands from a delivery configuration to a deployedconfiguration, and after the outer frame has expanded, advancing thedelivery system relative to the outer frame such that the inner frame isadvanced relative to the outer frame. The method further includesnesting the inner frame within the outer frame, and thereafter,releasing the first constraint from the first locking element such thatthe inner frame expands from a delivery configuration to a deployedconfiguration.

According to another example, (“Example 64”) further to Example 63, theinner frame and the outer frame are longitudinally offset from oneanother such that a proximal end of the inner frame is situated distalof a distal end of the outer frame.

According to another example, (“Example 65”) further to any of Examples63 and 64, the first constraint is release from the first stake memberby proximally withdrawing the first stake member.

According to another example (“Example 66”), further to any precedingexample the transcatheter delivery system includes a shaft extendingthrough a body portion and support portion of the system, the shaftincluding an enhanced flexibility portion proximal to the supportportion, the enhanced flexibility portion including a distal sectionhaving a cut pattern characterized by a first pitch and a proximalsection having a cut pattern characterized by a second pitch that isgreater than the first pitch.

According to another example, (“Example 67”), further to Example 66, thedistal section includes a distal transition portion having cut patterncharacterized by a third pitch that is greater than the first pitch.

The foregoing Examples are just that, and should not be read to limit orotherwise narrow the scope of any of the inventive concepts otherwiseprovided by the instant disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments, and together withthe description explain the principles of the disclosure.

FIG. 1 shows a transcatheter delivery system, according to someembodiments.

FIG. 2 is a side view of the delivery catheter of a transcatheterdelivery system, according to some embodiments.

FIG. 3 is a sectional view taken along line 3-3 in FIG. 2 and rotatedcounterclockwise ninety degrees, according to some embodiments.

FIG. 4 is an isometric, or perspective, view of a support portion of adelivery catheter, according to some embodiments.

FIG. 5A is a top-down view of a support portion of a delivery catheter,according to some embodiments.

FIG. 5B is a full section view of a delivery catheter taken along alongitudinal axis Xs from the top-down view of FIG. 5A, according tosome embodiments.

FIG. 6A is a top-down view of a support portion of a delivery catheter,according to some embodiments.

FIG. 6B is a full section view of a delivery catheter taken along alongitudinal axis Xs from the top-down view of FIG. 6A, according tosome embodiments.

FIG. 6C is a cross-sectional end view taken along line 6C-6C in FIG. 5A,according to some embodiments.

FIGS. 7A and 7B show optional features employable for a body portion anda support portion of a delivery catheter, according to some embodiments.

FIG. 8 shows the prosthetic valve in a cylindrical form as received overa support portion of a delivery catheter, according to some embodiments.

FIG. 9 is an isolated view showing a proximal constraint assembled witha proximal guide and a stake member, according to some embodiments.

FIG. 10 is an isolated view showing a distal constraint assembled with adistal guide and a stake member, according to some embodiments.

FIG. 11 is an isolated view showing an intermediate constraint assembledwith an intermediate guide and a stake member, according to someembodiments.

FIG. 12 shows a prosthetic valve received on a delivery catheter, withthe prosthetic valve in deployed or expanded state, according to someembodiments.

FIGS. 13A to 13D show additional designs for a frame portion that may beused for a prosthetic valve, according to various embodiments.

FIG. 14A shows a prosthetic valve in a compacted delivery state,according to some embodiments.

FIG. 14B shows a prosthetic valve partially retracted into a sheath,according to some embodiments.

FIGS. 15 to 18B show additional transcatheter delivery systemconfigurations, including additional guide configurations, according tosome embodiments.

FIGS. 19 and 20 show partial side views of additional embodiments of atranscatheter delivery system, according to some embodiments.

FIG. 21A shows a side view of a transcatheter delivery system, accordingto some embodiments.

FIG. 21B shows a sectional view taken along line B-B in FIG. 21A,according to some embodiments.

FIG. 21C shows a sectional view taken along line C-C in FIG. 21A,according to some embodiments.

FIG. 21D shows a sectional view taken along line D-D in FIG. 21A,according to some embodiments.

FIG. 21E shows a sectional view taken along line E-E in FIG. 21A,according to some embodiments.

FIG. 21F shows a sectional view taken along line F-F in FIG. 21A,according to some embodiments.

FIG. 21G shows a full section view of a transcatheter delivery systemtaken along a longitudinal axis of the system, according to someembodiments.

FIG. 21H shows an example of a delivery operation, according to someembodiments.

FIGS. 22A-22D show additional examples of designs for proximal, distal,and intermediate guides, according to some embodiments.

FIGS. 23A-23F show additional examples of designs for proximal, distal,and intermediate guides, according to some embodiments.

FIGS. 24A-24C and 25 show various examples of options for forming one ormore of a plurality of constraints, according to some embodiments.

FIGS. 26A-31 show examples of features usable for securing constraintsto a frame portion of an implantable device, according to someembodiments.

FIG. 32 is an isometric view of an actuation portion of a deliverycatheter in an assembled state, according to some embodiments.

FIG. 33 is an isometric view of the actuation portion of FIG. 32 in adisassembled state, according to some embodiments.

FIG. 34 is an isometric view of an assembly of an actuation portion andFIG. 35 is an enlarged view of the circled portion of FIG. 34, accordingto some embodiments.

FIG. 36 is an isometric view of a drive assembly of an actuationportion, according to some embodiments.

FIG. 37 is an isometric view of a nut portion and a gear portion of anactuation assembly of a delivery catheter, according to someembodiments.

FIGS. 38A and 38B are longitudinal sections of a portion of a deliverycatheter, according to some embodiments.

FIG. 38C is a partial longitudinal section of the portion of thedelivery catheter of FIGS. 38A and 38B, with additional componentsremoved to show an interaction between a slider and drive assembly ofthe delivery catheter, according to some embodiments.

FIG. 39 is an isometric view of a release assembly of a deliverycatheter, according to some embodiments.

FIG. 40 is an enlarged view of a distal coupling of a cathetersubassembly secured to a connector hub of a body portion of a deliverycatheter juxtaposed with a distal end of a slide rail, according to someembodiments.

FIGS. 41-44 are longitudinal cross sections of an actuation portion of adelivery catheter at various stages of operation, according to someembodiments.

FIG. 45 is a side view of another transcatheter delivery system,according to some embodiments.

FIG. 46 is a side view of another transcatheter delivery system,according to some embodiments.

FIG. 47 is a side view of another transcatheter delivery system,according to some embodiments.

FIG. 48 illustrates enhanced flexibility features of a shaft of adelivery catheter, according to some embodiments.

DETAILED DESCRIPTION

Various aspects of the disclosure relate to transcatheter deliverysystems that facilitate reduced delivery profiles, promote selectivedeployment at a desired position, and/or provide reducedcrimping/clamping forces on valve leaflet structures, among otheradditional or alternative features and advantages. Various examplesrelate to prosthetic valves used for cardiac valve replacement (e.g.,for treating a failing or otherwise defective aortic or mitral valve) orother applications associated with native valve or other valve orifices,and related systems, methods, and apparatuses. In some associatedtreatment methods, the prosthetic valve is utilized to treat valvestenosis (e.g., aortic valve stenosis) and/or valve insufficiency (e.g.,aortic valve insufficiency). Although features of transcatheter deliverysystems for prosthetic valves are generally shown and described in thepresent disclosure, similar features and principles of operation areemployable with other types of implantable devices, including stents,stent grafts, occluders, and vascular filters, for example, amongothers.

Unless otherwise indicated, where the terms “distal” and “proximal” areused in the instant disclosure in relation to features of deliverycatheters, those terms are generally used with reference to distal beingin a direction away from a user (e.g., away from a handle portion) ofthe delivery catheter and proximal in a direction toward a user (e.g.,toward the handle portion).

Unless otherwise indicated, where the terms “distal” and “proximal” areused in the instant disclosure in relation to features of prostheticvalves or other implantable devices, the term “distal” is generally usedto refer to an inflow end or a direction that is opposite that ofprimary flow through the device and proximal is generally used to referto an outflow end or direction of primary flow through the device.

FIG. 1 shows a transcatheter delivery system 10, including a sheath 12,a delivery catheter 14, and a prosthetic valve 16 maintained in acollapsed configuration by the delivery catheter 14. As shown, theprosthetic valve 16 is arranged on the delivery catheter 14 in adistally extended position from the sheath 12. Or, in different terms,the prosthetic valve 16 is in an extended position. As previouslyreferenced, the prosthetic valve 16 can be substituted with a variety ofself-expanding implantable devices, such as a stent, stent graft,occluder, or vascular filter, for example.

As shown, the sheath 12 is optionally an introducer sheath including ahemostatic valve 18, for example, although any of a variety ofadditional or alternative features are contemplated.

FIG. 2 is a side view of the delivery catheter 14, according to someembodiments. As shown, the delivery catheter 14 includes an actuationportion 20, a body portion 22, a support portion 24, a tip portion 26, aplurality of constraints 28, and a stake member 30.

In some embodiments, the actuation portion 20 optionally includes aplurality of spindles 32 that are each able to be rotated, including afirst spindle 34, a second spindle 36, and a third spindle 38. One ormore of the first spindle 34, the second spindle 36, and the thirdspindle 38 are optionally rotationally coupled to one another and/or areindependently rotatable as desired. For reference, the term “coupled”should be read in a broad sense to refer to direct or indirectattachment and to include both fixed and translatable attachment,depending upon context. Various forms of clutches, gears, or other meansfor controlling relative rotational speed, timing, or other interactionsbetween the spindles 32 are contemplated. Each of the first spindle 34,the second spindle 36 and the third spindle 38 is optionally configuredto be used to wind up, or tension, and let out, or de-tension, aconstraint received in the body portion 22 of the delivery catheter 14,as is subsequently described. Also, as subsequently described,additional designs for the actuation portion 20 are contemplated.

The body portion 22 defines a central longitudinal axis Xb and has aproximal section 40, a distal section 42, and an intermediate section 44between the proximal section 40 and the distal section 42, and aconnector hub 46. The body portion 22 is of suitable length for a user(not shown) to manipulate the delivery catheter 14 from a locationoutside the body of a patient into which the prosthetic valve 16 isbeing implanted. Generally, the body portion 22 is of sufficientflexibility, length, and column strength such that it is suitable fortraversing the vasculature or other bodily lumens and conduits within apatient (not shown).

FIG. 3 is a sectional view taken along line 3-3 in FIG. 2 and rotatedcounterclockwise ninety degrees, according to some embodiments. As shownin FIG. 3, the body portion 22 has a plurality of lumens 50 extendingwithin the body portion 22, which can also be described as passages orchannels. The plurality of lumens 50 extend the length of the bodyportion 22 through the proximal section 40, the distal section 42, andthe intermediate section 44 (FIG. 2). In some embodiments, the pluralityof lumens 50 include a stake member lumen 52, a first constraint lumen54, a second constraint lumen 56, a third constraint lumen 58, and acentral lumen 60, although any number of lumens (e.g., one, six, twelve,etc.), are contemplated. The stake member lumen 52, the first constraintlumen 54, the second constraint lumen 56, and the third constraint lumen58 are each optionally located at a desired angular position about thecentral longitudinal axis Xb of the body portion 22.

As shown, the stake member lumen 52 is at a position corresponding to 12o'clock or 0 degrees, the first constraint lumen 54 is at a positioncorresponding to 8 o'clock or 120 degrees, the second constraint lumen56 is at a position corresponding to 4 o'clock or 60 degrees, and thethird constraint lumen 58 is at a position corresponding to 6 o'clock,or 90 degrees. In some embodiments, the stake member lumen 52 ispositioned on one half of the transverse cross-section of the bodyportion 22 (e.g., the upper half as shown) and the first constraintlumen 54, the second constraint lumen 56, and the third constraint lumen58 are positioned on an opposite half of the transverse cross-section ofthe body portion 22 (e.g., the lower half as shown). Such positioningcan assist with balancing the overall design, including reducingunwanted bending and/or enhancing preferential bending/bendingflexibility in a desired direction, although a variety of features andconsiderations may be applicable. Though some examples of angularpositions are provided, any number of positions can be employed asdesired. As shown, the central lumen 60 may be positioned coaxially withthe longitudinal axis Xb of the body portion 22, although, again, anynumber of positions can be employed as desired.

As shown in FIG. 2, the proximal section 40 is coupled to and supportsthe actuation portion 20 such that the first spindle 34, the secondspindle 36 and the third spindle 38 are rotatable (e.g., transverse tothe longitudinal axis Xb of the body portion 22). Though not shown, oneor more of the first spindle 34, the second spindle 36, and the thirdspindle 38 optionally includes a handle or other feature to assist withoperation (e.g., rotation) thereof.

The distal section 42 is coupled to the support portion 24 andoptionally includes one or more features for assisting with passing thedistal section 42 into, out of, and/or through the sheath 12. Forexample, as shown in FIG. 2, the distal section 42 includes a flare 70,also described as a flange or taper, to provide an increased diametricprofile to the distal section 42 adjacent the support portion 24. Thisincreased diametric profile, also described as an outer transverseprofile, has a relatively smooth transition to reduce snagging ormechanical friction between the sheath 12 and the distal section 42 whenthe distal section 42 is slid through, extended from, and/or retractedinto the sheath 12 and through the vasculature or other conduits withina patient (not shown).

For reference, transverse outer profile may be calculated at atransverse cross-sectional location of a component by calculating thecross-sectional area defined by the outer surface at that location. Forsake of clarity, the cross-sectional area of the transverse outerprofile would include the area of any passages, channels, lumens, holes,etc. in the calculation. Alternatively, transverse outer profile may becalculated by taking a maximum diametric dimension defined by acomponent at the location.

As previously referenced, the intermediate section 44 is of sufficientflexibility, length, and column strength such that it is suitable fortraversing the vasculature or other bodily lumens or other conduitswithin a patient (not shown).

The connector hub 46 is optionally used to secure the body portion 22 tothe actuation portion 20 and/or other components and may include a luerconnector, seals, and/or other features as desired. In general terms,the plurality of constraints 28 and the stake member 30 optionally passthrough the connector hub 46 such that they can be coupled to theactuation portion 20.

FIG. 4 is an isometric, or perspective, view of the delivery catheter 14showing the support portion 24 in greater detail, according to someembodiments. The support portion 24 is generally configured to bereceived in the prosthetic valve 16 (FIG. 1) and to support theprosthetic valve 16 through delivery to, and deployment at a desiredtreatment location in a body of a patient (not shown). As shown, thesupport portion 24 extends from the distal section 42 of the bodyportion 22 and has a central longitudinal axis Xs. The support portion24 includes a shaft 80, a proximal guide 82, a distal guide 84, and anintermediate guide 86, according to some embodiments. Although threeguides 82, 84, 86 are shown, any number of guides (e.g., one, two, four,nine, etc.) are contemplated.

FIG. 5A is a top-down view of the delivery catheter 14 showing thesupport portion 24 and FIG. 5B is a sectional view of the deliverycatheter 14 taken along the longitudinal axis Xs from the top-down viewof FIG. 5A. FIG. 6A is a top-down view of the delivery catheter 14showing the support portion 24 and FIG. 6B is a sectional view of thedelivery catheter 14 taken along the longitudinal axis Xs from thetop-down view of FIG. 6A. FIG. 6C is a cross-sectional end view takenalong line 6C-6C in FIG. 5A for additional reference. The shaft 80 canbe flexible, relatively rigid, or combinations thereof. For example, theshaft 80 is optionally relatively more rigid (e.g., being a continuoushypotube) in the support portion 24 and relatively more flexible (e.g.,having cuts, reliefs or other features for enhancing flexibility) alongthe remainder of delivery catheter 14. The shaft 80 is elongate and asshown in FIG. 6B optionally includes a central lumen 89 (e.g., forreceiving a guidewire). As shown in FIG. 4 and FIG. 5A, the shaft 80 hasa central longitudinal axis (not separately labeled) that is coaxialwith the central longitudinal axis Xb of the body portion 22 and/or thecentral longitudinal axis Xs of the support portion 24. In otherexamples, however, the shaft 80 may be at a lateral offset (e.g.,parallel, but offset from) the central longitudinal axis Xb and/or Xs.

In various embodiments, the shaft 80 is formed as a hollow tube (e.g.,hypotube), for example using nitinol, stainless steel, or other metallicor polymeric materials. In various examples, the shaft 80 is configuredto receive a guidewire (not shown) for guiding the delivery catheter 14to a desired treatment location. If desired, however, the shaft 80 mayalso be formed as a solid member without any internal lumen. The shaft80 is optionally coupled to the tip portion 26 (e.g., inserted into andpress-fit or bonded to the tip portion 26), extends a length of thesupport portion 24, and may also form part of the body portion 22 (e.g.,extending through the central lumen 60 and out of the proximal end 206of the body portion 22). In different terms, the body portion 22 mayalso include the shaft 80. The shaft 80 is optionally a single, unitarymember, though separate connected components are also contemplated.

As shown in FIGS. 4, 5A, 5B, 6A, and 6B, the proximal guide 82 iscylindrical overall, having a transverse outer profile that iscylindrical, which also corresponds to a transverse outer profile thatis circular in transverse cross-section. As the transverse outer profileis cylindrical, the proximal guide 82 generally defines a maximumtransverse outer profile along the entire length of the proximal guide82. However, in other examples, the proximal guide 82 defines a maximumtransverse outer profile at one or more transverse cross-sections alongthe length of the proximal guide 82 and a minimum transverse outerprofile at one or more transverse cross-sections along the length of theproximal guide 82. For example, although cylindrical profiles arecontemplated, any of a variety of tapers, steps, chamfers and otherfeatures is also contemplated.

The proximal guide 82 defines a central longitudinal axis (notseparately labeled) that is coaxial with the central longitudinal axisXs of the support portion 24 and by transitive theory, the centrallongitudinal axis of the shaft 80, according to some examples.

As shown in FIG. 5B, in some embodiments, the proximal guide 82 includesa central lumen 88 through which the shaft 80 is received, for couplingthe proximal guide 82 to the shaft 80. As shown in FIG. 4, the proximalguide 82 also includes a plurality of passages 90, also described aschannels or lumens. As shown, the plurality of passages 90 include astake member passage 92, a first constraint passage 94, and a secondconstraint passage 96, although greater or fewer (e.g., one, four, ten,etc.) are contemplated. The stake member passage 92, the firstconstraint passage 94, and the second constraint passage 96 are eachoptionally located at a desired angular position about the centrallongitudinal axis Xs of the support portion 24.

As shown, the stake member passage 92 is at an angular positioncorresponding to 12 o'clock or 0 degrees, the first constraint passage94 is at an angular position corresponding to 11 o'clock, or −15degrees, and the second constraint passage 96 is at an angular positioncorresponding to 1 o'clock or 15 degrees. Though some examples ofangular positions are provided, any number of angular positions can beemployed as desired.

As seen with reference between FIGS. 4, 5A, 5B, 6A, and 6B, the distalguide 84 is substantially similar to the proximal guide 82. In someexamples, the distal guide 84 is also cylindrical overall, having atransverse outer profile that is cylindrical, which also corresponds toa transverse outer profile that is circular in transverse cross-section.As the transverse outer profile is cylindrical, the distal guide 84generally defines a maximum transverse outer profile along the entirelength of the distal guide 84. However, in other examples, the distalguide 84 defines a maximum transverse outer profile at one or moretransverse cross-sections along the length of the distal guide 84 and aminimum transverse outer profile at one or more transversecross-sections along the length of the proximal guide 82. For example,although cylindrical profiles that are circular in transversecross-section are contemplated, any of a variety of tapers, steps,chamfers and other features are also contemplated.

The distal guide 84 also defines a central longitudinal axis (notseparately labeled) that is coaxial with the central longitudinal axisXs of the support portion 24 and by transitive theory, the centrallongitudinal axis of the shaft 80 (as well as the proximal guide 82),according to some examples.

In some embodiments, the distal guide 84 includes a central lumen 100through which the shaft 80 is received, for coupling the distal guide 84to the shaft 80. As shown in FIG. 4, the distal guide 84 also includes aplurality of passages 102, also described as channels or lumens. Asshown, the plurality of passages 102 include a stake member passage 104,a first constraint passage 106, and a second constraint passage 108,although greater or fewer (e.g., one, four, ten, etc.) are contemplated.The stake member passage 104, first constraint passage 106, and secondconstraint passage 108 are each optionally located at a desired angularposition about the central longitudinal axis Xs of the support portion24.

As shown, the stake member passage 104 is at an angular positioncorresponding to 12 o'clock or 0 degrees, the first constraint passage106 is at an angular position corresponding to 11 o'clock, or −15degrees, and the second constraint passage 108 is at an angular positioncorresponding to 1 o'clock or 15 degrees. Though some examples ofangular positions are provided, any number of angular positions can beemployed as desired.

In some embodiments, each of the plurality of passages 90 of theproximal guide 82 is aligned with each of the plurality of passages 102of the distal guide 84. In other words, the stake member passage 104 isangularly aligned with the stake member passage 92, the first constraintpassage 106 with the first constraint passage 94, etc. In otherembodiments, one or more of the plurality of passages 90 and theplurality of passages 102 are angularly misaligned, or out of alignmentwith one another. Moreover, it should be readily appreciated that theproximal guide 82 need not have the same number of passages as thedistal guide 84.

In some embodiments, the angular position of the first constraintpassage 94 of the proximal guide 82 is angularly offset from the angularposition of the second constraint passage 108 of the distal guide 84 by10 to 350 degrees, although any variety of offsets are contemplated(e.g., 15 to 45 degrees). In some examples, the angular position of thefirst constraint passage 116 of the intermediate guide 86 is angularlyoffset from the angular position of the second constraint passage 108 ofthe distal guide 84 by 10 to 350 degrees, although a variety of offsetsare contemplated (e.g., 15 to 45 degrees).

As shown in FIGS. 4, 5A, 5B, 6A, and 6B, the intermediate guide 86 has areduced transverse outer profile, or a smaller transverse cross-section(e.g., as calculated comparing cross-sectional areas of the shapes ofthe respective transverse outer profiles) than the proximal guide 82, aswell as the distal guide 84.

For example, both the proximal guide 82 and distal guide 84 define atransverse outer profile that is circular in cross-section, and thusdefines a cross-sectional area that can be calculated by the simpleformula of the number pi multiplied by diameter of the proximal guide 82and/or distal guide 84 squared. For sake of clarity, the cross-sectionalarea of the transverse outer profile would include the area of anypassages, channels, lumens, holes, etc. in the calculation. And, formore complex transverse outer profiles, such as that of the intermediateguide 86, other mathematical methodology may be employed to calculatethe cross-sectional area of the transverse outer profile, according towell-understood principles. Alternatively, the transverse outer profilecan be calculated by taking the maximum diametric dimension (in thiscase, the outer diameter) of the proximal guide 82 and/or distal guide84.

In some examples, the cross-sectional area of the transverse outerprofile of the intermediate guide 86 is at least 20%, at least 30%, atleast 40%, at least 50%, at least 60%, or at least 80% less than that ofthe proximal guide 82 (e.g., the maximum and/or minimum transverse outerprofile) and/or distal guide 84 (e.g., the maximum and/or minimumtransverse outer profile), or any range of percentages between any ofthe foregoing percentages. As subsequently described, minimizing thecross-sectional area of the intermediate guide 86 may help reducecrimping forces on the prosthetic valve 16 and/or the overall deliveryprofile of the prosthetic valve 16 as received on the delivery catheter14, for example.

The intermediate guide 86 has a more irregular shape, having atransverse outer profile that is generally a rounded and truncatedpie-shape. Described in different terms, the intermediate guide 86 has atransverse outer profile that is trapezoidal in shape overall withconvex, or outward-facing curves at the top and the bottom and fourrounded corners.

As shown, the intermediate guide 86 has a constant transversecross-section along the length of the intermediate guide 86. As such,the transverse outer profile of the intermediate guide 86 issubstantially consistent along the length of the intermediate guide 86.And, in turn, the intermediate guide 86 generally defines a maximumtransverse outer profile along the entire length of the intermediateguide 86. However, in other examples, the intermediate guide 86 definesa maximum transverse outer profile at one or more transversecross-section positions along the length of the intermediate guide 86.For example, any of a variety of tapers, steps, chamfers and otherfeatures is also contemplated.

As shown in FIGS. 4 and 6C, the intermediate guide 86 also defines alongitudinal axis Xi that passes longitudinally through a center ofmass, or a center of inertia, of the maximum transverse outer profile ofthe intermediate guide 86. The longitudinal axis Xi is parallel to, andlaterally offset from the central longitudinal axes of the proximalguide 82 and the distal guide 84 (which correspond to the centrallongitudinal axis Xs), according to some examples.

As shown in FIGS. 5B and 6B, in some embodiments, the intermediate guide86 includes a central lumen 110 through which the shaft 80 is received,for coupling the intermediate guide 86 to the shaft 80. As shown in FIG.4, the intermediate guide 86 also includes a plurality of passages 112,also described as channels or lumens. As shown, the plurality ofpassages 112 include a stake member passage 114 and a first constraintpassage 116, although greater or fewer (e.g., one, three, ten, etc.) arecontemplated. The stake member passage 114 and first constraint passage116 are each located at a desired angular position about the centrallongitudinal axis Xs of the support portion 24.

As shown, the stake member passage 114 is at an angular positioncorresponding to 12 o'clock or 0 degrees and the first constraintpassage 116 is at an angular position corresponding to 11 o'clock or −15degrees. Though some examples of angular positions are provided, anynumber of angular positions can be employed as desired.

As shown in FIG. 6C, in some examples, the intermediate guide 86 has afirst side 120, a second side 122, a top 124, and a bottom 126. Asshown, the bottom 126 is positioned closer to the central lumen 110 thanthe top 124, such that the central lumen 110 is offset between the top124 and the bottom 126. This offset helps provide a packing, orreceiving space for receiving selected portions of the prosthetic valve16 that may benefit from additional space as part of compression of theprosthetic valve 16 onto the support portion 24 (e.g., a leaflet region262 as further described).

In some embodiments, each of the proximal guide 82, the distal guide 84,and the intermediate guide 86 is coupled to the shaft 80 (e.g., bywelding, crimping, press-fit, adhesives, or other techniques). In someexamples the shaft 80 maintains and supports each of the proximal guide82, distal guide 84, and intermediate guide 86 in alongitudinally-spaced relationship to one another andlongitudinally-spaced from the body portion 22 and the tip portion 26.As shown in FIGS. 5A and 5B, in this manner, the support portion 24defines a plurality of reduced profile sections 150, including aproximal reduced profile section 152 extending between the proximalguide 82 and the distal section 42 of the body portion 22, a firstreduced profile section 154 extending between the proximal guide 82 andthe intermediate guide 86, a second reduced profile section 156extending between the intermediate guide 86 and the distal guide 84, anda distal reduced profile section 158 extending between the distal guide84 and the tip portion 26. As shown, both the first reduced profilesection 154 and the second reduced profile section 156 are at locationsthat are intermediate or between the proximal guide 82 and the distalguide 84.

As shown, each of the reduced profile sections 150 is defined by atransverse outer profile of the shaft 80, which has the same maximum andminimum transverse outer profile through the length of the supportportion 24, and which is circular in transverse cross-section anddefines a transverse, cross-sectional area determined by pi multipliedby the diameter of the shaft 80 squared, although a variety of shapesare also contemplated for the shaft 80. The reduced profile sections 150can help provide a variety of advantages, including increasedflexibility in the support portion 24, additional space for receivingthe prosthetic valve 16 during compression onto the delivery catheter14, or others. For example, in some embodiments, each of the reducedprofile sections 150 has increased bending flexibility relative toadjacent sections of the support portion 24, such as the bendingflexibilities of the support portion 24 at the proximal guide 82, distalguide 84, and/or intermediate guide 86, although such feature may beabsent in other examples.

In some examples, the cross-sectional area of the transverse outerprofile of the shaft 80 (e.g., the maximum and/or minimum transverseouter profile) is at least 20%, at least 30%, at least 40%, at least50%, at least 60%, or at least 80% less than that of the proximal guide82 (e.g., the maximum and/or minimum transverse outer profile), suchthat the proximal reduced diameter section has a transverse outerprofile that is at least 20%, at least 30%, at least 40%, at least 50%,at least 60%, or at least 80% less than that of the proximal guide 82(or any range of percentages between any of the foregoing percentages).

In some examples, the cross-sectional area of the transverse outerprofile of the shaft 80 (e.g., the maximum and/or minimum transverseouter profile) is at least 20%, at least 30%, at least 40%, at least50%, at least 60%, or at least 80% less than that of the distal guide 84(e.g., the maximum and/or minimum transverse outer profile), such thatthe proximal reduced diameter section has a transverse outer profilethat is at least 20%, at least 30%, at least 40%, at least 50%, at least60%, or at least 80% less than that of the distal guide 84 (or any rangeof percentages between any of the foregoing percentages).

In some examples, the cross-sectional area of the transverse outerprofile of the shaft 80 (e.g., the maximum and/or minimum transverseouter profile) is at least 20%, at least 30%, at least 40%, at least50%, at least 60%, or at least 80% less than that of the intermediateguide 86 (e.g., the maximum and/or minimum transverse outer profile),such that the proximal reduced diameter section has a transverse outerprofile that is at least 20%, at least 30%, at least 40%, at least 50%,at least 60%, or at least 80% less than that of the intermediate guide86 (or any range of percentages between any of the foregoingpercentages).

In some examples, the cross-sectional area of the transverse outerprofile of the shaft 80 (e.g., the maximum and/or minimum transverseouter profile) is at least 20%, at least 30%, at least 40%, at least50%, at least 60%, or at least 80% less than that of the distal section42 of the body portion 22 (e.g., the maximum and/or minimum transverseouter profile), such that the proximal reduced diameter section has atransverse outer profile that is at least 20%, at least 30%, at least40%, at least 50%, at least 60%, or at least 80% less than that of thedistal section 42 of the body portion 22 (or any range of percentagesbetween any of the foregoing percentages).

As shown in FIGS. 6A and 6B, the tip portion 26 has a stake memberpassage 160 and a central lumen 162, and includes a proximal supportsection 164, and a distal nose section 166. The proximal support section164 has a reduced transverse outer profile relative to the distal nosesection 166 to define a recess for receiving a portion of the prostheticvalve 16. In general terms, the proximal support section 164 isoptionally configured to receive an end portion of the prosthetic valve16 with the adjacent, increased profile of the distal nose section 166assisting to protect the end of the prosthetic valve 16 (FIG. 1) fromsnagging or otherwise impeding delivery through the sheath 12 (FIG. 1)and within the patient's body (not shown).

The proximal support section 164 defines a transverse outer profile thatis circular in cross-section, and thus defines a cross-sectional areathat can be calculated by the simple formula of the number pi multipliedby diameter of the proximal support section 164 squared. Although acircular transverse cross-section is shown and described, any shape forthe transverse outer profile of the proximal support section 164 iscontemplated. For sake of clarity, the cross-sectional area of thetransverse outer profile would include the area of any channels, lumens,holes, etc. in the calculation (i.e., it would be treated as a solidcross-section for determining the transverse outer profilecross-sectional area). As previously referenced, the transverse outerprofile can alternative be calculated by taking the maximum diametricdimension.

As shown, the proximal support section 164 has a constant transversecross-section along the length of the proximal support section 164. Assuch, the transverse outer profile of the proximal support section 164is substantially consistent along the length of the proximal supportsection 164. And, in turn, the proximal support section 164 generallydefines a maximum transverse outer profile along the entire length ofthe proximal support section 164. However, in other examples, theproximal support section 164 defines a maximum transverse outer profileat one or more transverse cross-sectional positions along the length ofthe proximal support section 164. For example, any of a variety oftapers, steps, chamfers and other features are contemplated which wouldresult in a varying transverse outer profile.

The proximal support section 164 also defines a central longitudinalaxis (not separately labeled) that is coaxial with the centrallongitudinal axis Xs of the support portion 24, according to someexamples. As shown in FIGS. 5B and 6B, the shaft 80 is received in thecentral lumen 162 for coupling the proximal support section 164 to theshaft 80, and thus the support portion 24. As seen best in FIGS. 4, 5A,and 6B, the stake member passage 160 is located at a desired angularposition about the central longitudinal axis of the tip portion 26.

As shown, the stake member passage 160 is at an angular positioncorresponding to 12 o'clock or 0 degrees. Though an example of anangular position is provided, any number of angular positions can beemployed as desired. The angular position of the stake member passage160 optionally corresponds to the angular position of the stake memberlumen 52 of the body portion 22, the stake member passage 92 of theproximal guide 82, the stake member passage 104 of the distal guide 84,according to some examples.

In some examples, the cross-sectional area of the transverse outerprofile of the shaft 80 (e.g., the maximum and/or minimum transverseouter profile) is at least 20%, at least 30%, at least 40%, at least50%, at least 60%, or at least 80% less than that of the proximalsupport section 164 of the tip portion 26 (e.g., the maximum and/orminimum transverse outer profile), such that the proximal reduceddiameter section has a transverse outer profile that is at least 20%, atleast 30%, at least 40%, at least 50%, at least 60%, or at least 80%less than that of the proximal support section 164 of the tip portion 26(or any range of percentages between any of the foregoing percentages).

Various additions and/or alterations are contemplated for the deliverycatheter 14. For example, FIGS. 7A and 7B show some optional featuresemployable for the body portion 22 and the support portion 24. As shown,the body portion 22 has a step 176 in the distal section 42 forproximally supporting the prosthetic valve 16. Also, the deliverycatheter 14 optionally includes a cover 178 (e.g., a thin layer ofmaterial, such as ePTFE or a thin heat shrunk tube of PET) over thesupport portion 24, extending over the proximal guide 82, the distalguide 84, and the intermediate guide 86. As shown, the cover 178 alsooptionally extends over the proximal support section 164 of the tipportion 26 and the step 176. The cover 178 includes apertures or otheropenings (not shown) from which the plurality of constraints 28 (FIG. 2)are able to pass. Additionally, as shown in FIGS. 7A and 7B, theproximal guide 82 and the intermediate guide 86 are each taperedproximally improve the ability to withdraw the delivery catheter 14 backthrough the deployed prosthetic valve 16 and/or into and through thesheath 12.

As shown in FIG. 2, the plurality of constraints 28 comprise a proximalconstraint 180, a distal constraint 182, and an intermediate constraint184. In some embodiments, each of the plurality of constraints 28 isformed as a fiber, strand, wire, combinations thereof or the like, andmay be braided, wound, extruded, or otherwise formed of metallic orpolymeric materials. In general terms, each of the plurality ofconstraints 28 may be described as a filament that is elongate andflexible. For reference, the term “filament” is inclusive of bothmonofilament and multifilament constructs. In some examples, each of theconstraints 28 may be formed from braided strands of material, such asUHMWPE or ePTFE. Although three are shown, any number of constraints 28(e.g., one, two, four, nine, etc.) are contemplated. In someembodiments, the proximal constraint 180 includes a catch 190 in theform of a terminal, closed loop or eyelet, for example. The catch 190 isoptionally formed using braiding methods (e.g., by twisting the braidinto itself or through a continuous braiding method that forks a singlestrand into two separates strands and then rebraids them into a singlestrand to form an eyelet). The distal constraint 182 similarly includesa catch 192 as does the intermediate constraint 184, which includes acatch 194. FIGS. 24A-24C and 24 provide various examples for forming oneor more of the plurality of constraints 28.

FIGS. 2, 3, and 6B show the stake member 30, which can also be describedas a lock wire, from various views. In some embodiments, the stakemember 30 is formed as a wire, strand, fiber or the like, and may bebraided, wound, extruded, or otherwise formed of metallic or polymericmaterials. In some examples, the stake member 30 is a wire formed ofstainless steel, nitinol, or other material. As seen in FIG. 6B, thestake member 30 extends from a proximal end 30 a into the proximalsection 40 of the body portion 22 into the stake member lumen 52,through the body portion 22, out of the distal section 42 of the bodyportion 22 from the stake member lumen 52 (FIG. 3), through the stakemember passage 92 (FIG. 6B) of the proximal guide 82, through the stakemember passage 104 (FIG. 6B) of the distal guide 84, through the stakemember passage 114 (FIG. 6B) of the intermediate guide 86, and into thestake member passage 160 (FIG. 6B) of the tip portion 26. The stakemember 30 is slidably received in the stake member lumen 52 andrespective passages so that the stake member 30 is retractable from theproximal guide 82, the distal guide 84, and the intermediate guide 86,as subsequently described.

FIG. 8 shows the prosthetic valve 16 in a generalized, cylindrical formfor ease of visualization as received over the support portion 24 of thedelivery catheter 14, with the proximal constraint 180, the distalconstraint 182, and the intermediate constraint 184 looped around theprosthetic valve 16, each in a releasable, looped configuration.Assembly of the delivery catheter 14 includes assembly of the prostheticvalve 16 onto the delivery catheter 14 and assembly of the proximalconstraint 180, the distal constraint 182, and the intermediateconstraint 184 into the respective proximal guide 82, distal guide 84,and intermediate guide 86 and circumferentially around the prostheticvalve 16. As indicated, the prosthetic valve 16 is received over thedelivery catheter 14, with the delivery catheter 14 received within theprosthetic valve 16 in a laterally offset position.

FIG. 9 is an isolated view showing the proximal constraint 180 assembledwith the proximal guide 82 and the stake member 30. The prosthetic valve16 and other portions are removed to facilitate understanding how theproximal constraint 180 is secured in a looped configuration, to definea proximal constraining loop 195, according to some embodiments. In someembodiments, the proximal constraint 180 is received by the firstspindle 34 (FIG. 2) such that it is windable onto the first spindle 34and passes into the first constraint lumen 54 of the body portion 22(FIG. 3). The proximal constraint 180 then passes out of the firstconstraint lumen 54 (FIG. 3) into one of the plurality of passages 90(FIG. 4) of the proximal guide 82 (e.g., the first constraint passage 94as shown), extends through the one of the plurality of passages 90(e.g., the first constraint passage 94), and distally out of the one ofthe plurality of passages 90 (e.g., the first constraint passage 94 asshown) and then radially away from the central longitudinal axis Xs ofthe support portion 24.

The proximal constraint 180 then loops about the support portion 24,crosses over itself, and is secured to the stake member 30 with thestake member 30 received through the catch 190. Proximally tensioningthe proximal constraint 180, for example with the first spindle 34 ofthe actuation portion 20 (FIG. 2), causes the proximal constraining loop195 to constrict, reducing the diameter of the proximal constrainingloop 195 and thus results in a collapsing or constraining force withinthe proximal constraining loop 195. In turn, release of the tensionpermits the proximal constraining loop 195 to expand.

Similarly, FIG. 10 is an isolated view showing the distal constraint 182assembled with the distal guide 84 and the stake member 30 (again, withthe prosthetic valve 16 and other portions removed to facilitateunderstanding), according to some embodiments. In some embodiments, thedistal constraint 182 is received by the second spindle 36 (FIG. 2) suchthat it is windable onto the second spindle 36 and passes into thesecond constraint lumen 56 of the body portion 22 (FIG. 3). The distalconstraint 182 then passes out of the second constraint lumen 56 (FIG.3) into one of the plurality of passages 90 of the proximal guide 82(e.g., the second constraint passage 96 as shown), extends through theone of the plurality of passages 90 (e.g., the second constraint passage96 as shown), and distally out of the one of the plurality of passages90 (e.g., the second constraint passage 96 as shown).

The distal constraint 182 then extends past the intermediate guide 86,on one side of the intermediate guide 86 (e.g., the first side 120 asshown) on its way to the distal guide 84.

The distal constraint 182 then enters one of the plurality of passages102 (FIG. 4) of the distal guide 84 (e.g., the second constraint passage108 as shown), and distally out of the one of the plurality of passages102 (e.g., second constraint passage 108). The distal constraint 182then extends radially away from the central longitudinal axis Xs of thesupport portion 24, loops about the support portion 24, crosses overitself, and is secured to the stake member 30 with the stake member 30received through the catch 192 of the distal constraint 182 to define adistal constraining loop 196. Proximally tensioning the distalconstraint 182, for example with the second spindle 36 of the actuationportion 20 (FIG. 2), causes the distal constraining loop 196 toconstrict, and thus results in a collapsing or constraining force withinthe distal constraining loop 196 reducing a diameter of the distalconstraining loop 196. In turn, release of the tension permits thedistal constraining loop 196 to expand.

FIG. 11 is a similar, isolated view showing the intermediate constraint184 assembled with the intermediate guide 86 and the stake member 30(again, with the prosthetic valve 16 removed to facilitateunderstanding), according to some embodiments. In some embodiments, theintermediate constraint 184 is received by the third spindle 38 (FIG. 2)such that it is windable onto the third spindle 38 and passes into thethird constraint lumen 58 (FIG. 3) of the body portion 22. Theintermediate constraint 184 then passes out of the third constraintlumen 58 into one of the plurality of passages 90 of the proximal guide82 (e.g., the second constraint passage 96 as shown), extends throughthe one of the plurality of passages 90 (e.g., the second constraintpassage 96 as shown), and distally out of the one of the plurality ofpassages 90 (e.g., the second constraint passage 96 as shown).

The intermediate constraint 184 then extends into and enters one of theplurality of passages 112 (e.g., the first constraint passage 116 asshown), and distally out of the one of the plurality of passages 112(e.g., the first constraint passage 116 as shown). The intermediateconstraint 184 then extends radially away from the central longitudinalaxis Xs of the support portion 24, then loops about the support portion24, crosses over itself, and is secured to the stake member 30 with thestake member 30 received through the catch 194 of the intermediateconstraint 184 to define an intermediate constraining loop 197.Proximally tensioning the intermediate constraint 184, for example withthe third spindle 38 of the actuation portion 20 (FIG. 2), causes theintermediate constraining loop 197 to constrict, and thus results in acollapsing or constraining force within the intermediate constrainingloop 197 reducing a diameter of the intermediate constraining loop 197.In turn, release of the tension permits the distal constraining loop 196to expand.

FIG. 12 shows the prosthetic valve 16 received on the delivery catheter14, with the prosthetic valve in deployed, or expanded state, accordingto some embodiments. In some examples, the prosthetic valve 16 is aprosthetic heart valve, such as a prosthetic valve for aortic valve ormitral valve replacement/repair. As shown, the prosthetic valve 16 has acentral longitudinal axis Xv, a proximal portion 200, also described asan end portion, a distal portion 202, also described as an end portion,and an intermediate portion 204, also described as a mid-portion, andextends between a proximal end 206 and a distal end 208, according tosome embodiments. The prosthetic valve 16 includes a frame portion 210that is self-expanding (e.g., formed of a shape memory alloy, such asnitinol) and a cover 212, and a leaflet construct 214 (hidden, but shownin broken lines) operatively coupled to the frame portion 210 (e.g.,directly attached or indirectly attached to the frame portion 210 viathe cover 212).

As shown, the frame portion 210 has a distal end 220 and a proximal end222 and includes a plurality of rows of frame members 224 defining anundulating, alternating pattern of distal-facing apices 226 andproximal-facing apices 228. In some embodiments, the plurality of rowsof frame members 224 include a distal row 230 at the distal end 220 ofthe frame portion 210 and a proximal row 232 at the proximal end 222 ofthe frame portion 210. The frame portion 210 also includes a pluralityof rows of closed cells 240 defined by the plurality of frame members224, each of the plurality of rows of closed cells 240 having a distalend 242, a proximal end 244, and a mid-portion 246 between the proximalend 244 and the distal end 242. In some examples, the plurality of rowsof closed cells 240 includes a distal row of closed cells 250 at thedistal end 220 of the frame portion 210 and a proximal row of closedcells 252 at the proximal end 222 of the frame portion 210. FIGS. 13A to13D show additional designs for the frame portion 210 that may be usedfor the prosthetic valve 16, according to various embodiments. As shown,each of the designs includes a plurality of commissure attachmentregions 224P (such as commissure posts) configured for supportingcommissure regions of a leaflet construct.

In some embodiments, the leaflet construct 214 includes a plurality ofleaflets 260 (hidden, but labeled with a broken line) that coapt withone another to form a one-way valve. The location or position of theleaflet construct 214 along the length of the prosthetic valve 16 isreferenced as a leaflet region 262 or leaflet portion. Various leafletmaterials and constructions are contemplated, including the examplesthat are subsequently described.

In some embodiments, the cover 212 has one or more rows of apertures 270for receiving one or more of the proximal constraint 180, the distalconstraint 182, and the intermediate constraint 184. For example, therows of apertures 270 optionally include a distal row of apertures 272(e.g., defined in the cover 212 along the mid-portion 246 of the distalrow of closed cells 250), a proximal row of apertures 274 (e.g., definedin the cover 212 along the mid-portion 246 of the proximal row of closedcells 252), and an intermediate row of apertures 276 (defined in thecover 178 along the mid-portion 246 of another one of the plurality ofrows of closed cells 240).

FIG. 12 shows a location of the proximal constraint 180, the distalconstraint 182, and the intermediate constraint 184 in relation to theprosthetic valve 16, according to some embodiments. As shown, the distalconstraint 182, and thus the distal constraining loop 196 (FIG. 10),circumscribes the distal row of closed cells 250 at the mid-portion 246of the distal row of closed cells 250 and the proximal constraining loop195 (FIG. 9) circumscribes the proximal row of closed cells 252 at themid-portion 246 of the proximal row of closed cells 252. As shown, thedistal constraining loop 196 circumscribes the distal row of closedcells 250 at a position proximal to the distal-facing apices 226 of thedistal row of closed cells 250 and the proximal constraining loop 195circumscribes the proximal row of closed cells 252 at a position distalto the proximal-facing apices 228 of the proximal row of closed cells252. In some examples, the intermediate constraining loop 197 (FIG. 11)circumscribes the prosthetic valve 16 at a location between the proximalconstraining loop 195 and the distal constraining loop 196 and whichalso corresponds to the leaflet region 262.

As shown in FIG. 12, in some examples, the distal constraining loop 196(FIG. 10) is woven through the distal row of apertures 272 such that thedistal constraint 182 extends outside over the frame members 224. Insome embodiments, the proximal constraint 180 and the intermediateconstraint 184 are similarly woven through the proximal row of apertures274 and intermediate row of apertures 276, respectively, such that theproximal constraining loop 195 (FIG. 9) and the intermediateconstraining loop 197 (FIG. 11) extend over the frame members 224. Inother examples, the proximal constraint 180, the distal constraint 182,and/or the intermediate constraint 184 are woven through the frameportion 210 using an alternative weaving pattern (e.g., in anover-and-under pattern relative to the frame portion 210 through therows of closed cells 240).

In some embodiments, the proximal constraint 180 exits the proximalguide 82 passes out of the prosthetic valve 16, encircles the prostheticvalve 16, and defines a crossing-point 300 (indicated generally on FIG.9 without the prosthetic valve 16 for visualization purposes) where theproximal constraint 180 passes over itself in a cinch arrangement priorto passing back through the prosthetic valve 16 and to the stake member30. Similarly, in some embodiments, the distal constraint 182 exits thedistal guide 84 passes out of the prosthetic valve 16, encircles theprosthetic valve 16, and defines a crossing-point 302 (indicatedgenerally on FIG. 10 without the prosthetic valve 16 for visualizationpurposes) where the distal constraint 182 passes over itself in a cincharrangement prior to passing back through the prosthetic valve 16 and tothe stake member 30. Again, in some embodiments, the intermediateconstraint 184 exits the intermediate guide 86 passes out of theprosthetic valve 16, encircles the prosthetic valve 16, and defines acrossing-point 304 (indicated generally on FIG. 11 without theprosthetic valve 16 for visualization purposes) where the intermediateconstraint 184 passes over itself in a cinch arrangement prior topassing back through the prosthetic valve 16 and to the stake member 30.

FIGS. 13A-13D show additional locations for the proximal constrainingloop 195, the distal constraining loop 196, and the intermediateconstraining loop 197 in accordance with other embodiments of the frameportion 210. As shown the proximal constraining loop 195, the distalconstraining loop 196, and the intermediate constraining loop 197 neednot each extend over the m id-portion 246 of each of the plurality ofrows of closed cells 240. For example, the distal constraining loop 196may simply circumscribe the distal row of closed cells 250 at a positionproximal to the distal-facing apices 226 of the distal row of closedcells 250. Additionally or alternatively, the proximal constraining loop195 circumscribes the proximal row of closed cells 252 at a positiondistal to the proximal-facing apices 228 of the proximal row of closedcells 252.

As shown in FIG. 8, the central longitudinal axis Xv of the prostheticvalve 16 is optionally laterally offset from the central longitudinalaxis Xs of the support portion 24. In some examples, the prostheticvalve 16 is received over the support portion 24 with the supportportion 24 positioned adjacent a commissure post (not shown) of theprosthetic valve 16 and/or at an intersection of two leaflets (notshown) of the prosthetic valve 16. As shown in FIGS. 8 and 12, theprosthetic valve 16 is received over the support portion 24 with theproximal portion 200 over the proximal guide 82, the distal portion 202over the distal guide 84, and the intermediate portion 204 over theintermediate guide 86. In some embodiments, the leaflet region 262 (FIG.12) is positioned on the support portion 24 between the proximal guide82 and the distal guide 84. For example, in some embodiments, theleaflet region 262 does not extend longitudinally beyond the proximalguide 82 and the distal guide 84. As previously referenced, the firstreduced profile section 154 and the second reduced profile section 156are at locations that are intermediate or between the proximal guide 82and the distal guide 84 and provide additional area for the leafletconstruct 214 (FIG. 12) both prior to and during compression of theprosthetic valve 16 onto the support portion 24. Moreover, therelatively reduced profile of the intermediate guide 86 can help providespace for the leaflet construct 214.

FIG. 14A shows the prosthetic valve 16 in a compacted, delivery statewith each of the proximal constraining loop 195, the distal constrainingloop 196, and the intermediate constraining loop 197 restraining theprosthetic valve 16 in the delivery state. As shown, the proximalconstraining loop 195 is positioned along the proximal portion 200 ofthe prosthetic valve 16 at a location on the frame portion 210 (FIG. 12)that causes the proximal portion 200 to take on a tapered, compressedtransverse outer profile, or tapered configuration, that assists withwithdrawing and/or extending the prosthetic valve 16 into and/or fromthe sheath 12 as understood with reference to FIG. 14B. Thus, accordingto some embodiments, the proximal end 206 of the prosthetic valve 16defines a reduced transverse outer profile as compared to adjacentportions of the prosthetic valve 16.

Similarly, the distal constraining loop 196 is positioned along thedistal portion 202 of the prosthetic valve 16 at a location on the frameportion 210 that causes the proximal portion 200 to take on a tapered,compressed transverse outer profile, or tapered configuration, thatassists with extending and/or withdrawing the prosthetic valve 16 fromand/or into the sheath 12 as shown in FIG. 14B. By placing the proximalconstraining loop 195 and the distal constraining loop 196 at thepositions previously described, the proximal constraining loop 195causes the proximal row of closed cells 252 (FIG. 12) to hinge, orangulate more inward and the distal row of closed cells 250 (FIG. 12) tohinge or angulate more inward. And thus, according to some embodiments,the distal end 208 of the prosthetic valve 16 defines a reducedtransverse outer profile as compared to adjacent portions of theprosthetic valve 16 (FIG. 12).

FIGS. 15 to 18B show various features of another support portion 524that can be utilized with the delivery catheter 14 of the transcatheterdelivery system 10, where the support portion 524 utilizes additional oralternative guide configurations to those described for the supportportion 24. As previously referenced, any number of guides (e.g., one,two, four, nine, etc.) may be implemented as desired. The variousfeatures and components of the support portion 524 may be usedinterchangeably with any of the components of the support portion 24previously described (and vice versa).

FIG. 15 is an isometric, or perspective, view of a portion of thedelivery catheter 14 showing the support portion 524 in greater detail,according to some embodiments. Like the support portion 24, the supportportion 524 is generally configured to be received in the prostheticvalve 16 (FIG. 1) and to support the prosthetic valve 16 throughdelivery to, and deployment at a desired treatment location in a body ofa patient (not shown). As shown, the support portion 524 extends fromthe distal section 42 of the body portion 22 and has a centrallongitudinal axis Xs. The support portion 524 includes a portion of theshaft 80, a support guide 562, a proximal guide 582, a distal guide 584,and an intermediate guide 586, according to some embodiments.

In some embodiments, each of the support guide 562, the proximal guide582, the distal guide 584, and the intermediate guide 586 is coupled tothe shaft 80 (e.g., by welding, crimping, press-fit, adhesives, or othertechniques) to maintain and support each of the respective guides in alongitudinally-spaced relationship to one another andlongitudinally-spaced from the body portion 22 and the tip portion 26.

FIG. 16 is a distal-oriented isometric view and FIG. 17 is aproximal-oriented isometric view of the support guide 562. As shown inFIGS. 16 and 17, the support guide 562 includes a central lumen 564configured to receive the shaft 80 for coupling the support guide 562 tothe shaft 80. As shown, the support guide 562 also includes a pluralityof passages 566, also described as channels or lumens. As shown, theplurality of passages 566 include a stake member passage 568, a firstconstraint passage 570, a second constraint passage 572, and a thirdconstraint passage 574, although greater or fewer (e.g., one, four, ten,etc.) are contemplated. The plurality of passages 566 are eachoptionally located at a desired angular position about the centrallongitudinal axis Xs of the support portion 524.

As shown in FIGS. 16 and 17, the support guide 562 has a rounded, orhemispherical, or dome-shaped proximal end 576 and a stepped distal end578, also described as a recess 578, that defines a support surface 580(e.g., like step 176 shown in FIG. 7B) for receiving an end of theprosthetic valve 16. In general terms, the support surface 580 of thedistal end 578 is optionally configured to receive an end portion of theprosthetic valve 16 with the adjacent, increased profile of the distalend 578 assisting to protect the end of the prosthetic valve 16.

In some embodiments, the plurality of passages 566 are generallypositioned on opposite radial sides from the first constraint lumen 54,the second constraint lumen 56, and the third constraint lumen 58 of thebody portion 22 (e.g., which are positioned on the lower half of thebody 22 as shown). Such positioning can assist with balancing theoverall design, including reducing unwanted bending and/or enhancingpreferential bending/bending flexibility in a desired direction. Forexample, the various constraints 28 can optionally be tensioned on aside of the delivery catheter 14 opposite the direction the prostheticvalve 16 is to be expanded during deployment. Though some examples ofangular positions are provided, any number of positions can be employedas desired.

FIG. 18A is an isometric view of the proximal guide 582, according tosome embodiments. As shown in FIG. 18A, the proximal guide 582 hassubstantially the same configuration as the intermediate guide 86 of thesupport portion 24. In turn, the distal guide 584 and the intermediateguide 586 are shown to each have substantially the same configuration asthe distal guide 84 of the support portion 24 (or the proximal guide 82of the support portion 24).

In some embodiments, the proximal guide 582 includes a central lumen 588through which the shaft 80 is received, for coupling the proximal guide582 to the shaft 80. As shown, the proximal guide 582 also includes aplurality of passages 590, also described as channels or lumens. Asshown, the plurality of passages 590 include a stake member passage 592and a first constraint passage 594, although greater or fewer (e.g.,one, four, ten, etc.) are contemplated. The stake member passage 592 andthe first constraint passage 594 are each optionally located at adesired angular position about the central longitudinal axis Xs of thesupport portion 524.

Some features of the proximal guide 582 may vary from the design of theintermediate guide 86. For example, as shown in FIGS. 15 and 18A, theproximal guide 582 optionally includes recessed or cut back areas 582Asuch that additional material is removed relative to the design of theintermediate guide 86, which can help further reduce the outer profileof the proximal guide 582 from that described in association with theintermediate guide 86. Additionally or alternatively, as shown in FIG.18B, the proximal guide 582 optionally defines an open shaft receiver582B (rather than a closed lumen as shown in FIG. 18A) for receiving theshaft 80 (FIG. 15). This feature, the open shaft receiver 582B may alsoachieve reduced material relative to the intermediate guide 86. Wherethe open shaft receiver 582B is present, rather than the shaft 80 beingreceived in a closed lumen such as the central lumen 588 (e.g., as inFIGS. 15 and 18A), the proximal guide 582 receives the shaft 80 in theopen shaft receiver 582B and may be welded along the edges and/or endsto secure the proximal guide 582 to the shaft 80.

As shown in FIG. 15, the distal guide 584 is substantially similar to,or the same design as, the intermediate guide 586, which are both, inturn, similar to the proximal guide 82 and the distal guide 84 of thesupport portion 524 in design. As shown, the distal guide 584 and theintermediate guide 586 are each cylindrical overall, having a transverseouter profile that is cylindrical, which also corresponds to atransverse outer profile that is circular in transverse cross-section.

In some embodiments, the distal guide 584 includes a plurality ofpassages 602, also described as channels or lumens. As shown, theplurality of passages 602 include a stake member passage 604, a firstconstraint passage 606, and a second constraint passage 608, althoughgreater or fewer (e.g., one, four, ten, etc.) are contemplated. Thestake member passage 604, the first constraint passage 606, and thesecond constraint passage 608 are each optionally located at a desiredangular position about the central longitudinal axis Xs of the supportportion 524.

In some embodiments, the stake member passage 604 is angularly alignedwith the stake member passage 592. In some embodiments, one or more ofthe plurality of passages 590 and the plurality of passages 602 areangularly misaligned, or out of alignment with one another. Moreover, itshould be readily appreciated that the proximal guide 582 may have thesame number of passages as the distal guide 584 or a different number(as shown).

As shown, the proximal guide 582 has a reduced transverse outer profile,or a smaller transverse cross-section (e.g., as calculated comparingcross-sectional areas of the shapes of the respective transverse outerprofiles) than the distal guide 584 and the intermediate guide 586. Insome examples, the cross-sectional area of the transverse outer profileof the proximal guide 582 is at least 20%, at least 30%, at least 40%,at least 50%, at least 60%, or at least 80% less than that of the distalguide 584 (e.g., the maximum and/or minimum transverse outer profile)and/or intermediate guide 586 (e.g., the maximum and/or minimumtransverse outer profile), or any range of percentages between any ofthe foregoing percentages. Minimizing the cross-sectional area may helpreduce crimping forces on the leaflet area of the prosthetic valve 16and/or the overall delivery profile of the prosthetic valve 16 asreceived on the delivery catheter 14, for example.

As shown in FIG. 15, the intermediate guide 586 includes a central lumen610 through which the shaft 80 is received, for coupling theintermediate guide 586 to the shaft 80. The intermediate guide 586 alsoincludes a plurality of passages 612, also described as channels orlumens. As shown, the plurality of passages 612 include a stake memberpassage 614, a first constraint passage 616, and a second constraintpassage 618, although greater or fewer (e.g., one, three, ten, etc.) arecontemplated. The stake member passage 614, the first constraint passage616, and the second constraint passage 618 are each located at a desiredangular position about the central longitudinal axis Xs of the supportportion 524.

In some embodiments, the stake member passage 604 is angularly alignedwith the stake member passage 614, the first constraint passage 606 isangularly aligned with the first constraint passage 616, and the secondconstraint passage 608 is angularly aligned with the second constraintpassage 618. In other embodiments, one or more of the plurality ofpassages 602 and the plurality of passages 612 are angularly misaligned,or out of alignment with one another. Moreover, it should be readilyappreciated that the intermediate guide 586 may have a different numberof passages than the distal guide 584 in other examples.

In some embodiments, the stake member passage 568 is angularly alignedto each of the stake member passages 592, 604, 614, as well as the stakemember passage 160 of the tip portion 26 (FIG. 6B). In some embodiments,the first constraint passage 570 is angularly aligned to the firstconstraint passage 594. In some embodiments, the second constraintpassage 572 is angularly aligned to the first constraint passage 616. Insome embodiments, the third constraint passage 574 is angularly alignedto the second constraint passages 608, 618.

As shown in FIG. 15, the support portion 524 defines a plurality ofreduced profile sections 650, including a proximal reduced profilesection 652 extending between the proximal guide 582 and the supportguide 562, a first reduced profile section 654 extending between theproximal guide 582 and the intermediate guide 586, a second reducedprofile section 656 extending between the intermediate guide 586 and thedistal guide 584, and a distal reduced profile section 658 extendingbetween the distal guide 584 and the tip portion 26. Additionally, aproximate reduced profile section 660 is defined between the supportguide 562 and the distal section 42 of the body portion 22. As shown,both the first reduced profile section 654 and the second reducedprofile section 656 are at locations that are intermediate or betweenthe proximal guide 582 and the distal guide 584.

In some examples, the cross-sectional area of the transverse outerprofile of the shaft 80 (e.g., the maximum and/or minimum transverseouter profile) is at least 20%, at least 30%, at least 40%, at least50%, at least 60%, or at least 80% less than that of the support guide562 (e.g., the maximum and/or minimum transverse outer profile), suchthat the proximal reduced diameter section has a transverse outerprofile that is at least 20%, at least 30%, at least 40%, at least 50%,at least 60%, or at least 80% less than that of the support guide 562(or any range of percentages between any of the foregoing percentages).

In some examples, the cross-sectional area of the transverse outerprofile of the shaft 80 (e.g., the maximum and/or minimum transverseouter profile) is at least 20%, at least 30%, at least 40%, at least50%, at least 60%, or at least 80% less than that of the proximal guide582 (e.g., the maximum and/or minimum transverse outer profile), suchthat the proximal reduced diameter section has a transverse outerprofile that is at least 20%, at least 30%, at least 40%, at least 50%,at least 60%, or at least 80% less than that of the proximal guide 582(or any range of percentages between any of the foregoing percentages).

In some examples, the cross-sectional area of the transverse outerprofile of the shaft 80 (e.g., the maximum and/or minimum transverseouter profile) is at least 20%, at least 30%, at least 40%, at least50%, at least 60%, or at least 80% less than that of the distal guide584 (e.g., the maximum and/or minimum transverse outer profile), suchthat the proximal reduced diameter section has a transverse outerprofile that is at least 20%, at least 30%, at least 40%, at least 50%,at least 60%, or at least 80% less than that of the distal guide 584 (orany range of percentages between any of the foregoing percentages).

In some examples, the cross-sectional area of the transverse outerprofile of the shaft 80 (e.g., the maximum and/or minimum transverseouter profile) is at least 20%, at least 30%, at least 40%, at least50%, at least 60%, or at least 80% less than that of the intermediateguide 586 (e.g., the maximum and/or minimum transverse outer profile),such that the proximal reduced diameter section has a transverse outerprofile that is at least 20%, at least 30%, at least 40%, at least 50%,at least 60%, or at least 80% less than that of the intermediate guide586 (or any range of percentages between any of the foregoingpercentages).

In some embodiments, the stake member 30 is received in each of thestake member passages 160, 568, 592, 604, 614 to secure the respectiveconstraints 28 in loops for constraining the prosthetic valve 16. Thoughthe constraints 28 are not shown in FIG. 15, reference can be made toFIGS. 8 to 11 with regard to the constraint features referenced below inassociation with assembly and operation of the support portion 524.

In contrast to the described-configuration with the support portion 24,in some embodiments implementing the support portion 524, the proximalconstraint 180 passes through and out of the second constraint lumen 56(FIG. 3) into and through one of the passages 566 of the support guide562 (e.g., the first constraint passage 570). The proximal constraint180 then passes into and through one of the plurality of passages 590 ofthe proximal guide 582 (e.g., the first constraint passage 594),distally out of the one of the plurality of passages 590 (e.g., thefirst constraint passage 594) and then radially away from the centrallongitudinal axis Xs of the support portion 524 to loop about thesupport portion 524, cross over itself, and be secured to the stakemember 30 with the stake member 30 received through the catch 190.

Similar to the support portion 24, proximally tensioning the proximalconstraint 180, for example with the first spindle 34 of the actuationportion 20 (FIG. 2), causes the proximal constraining loop 195 toconstrict, reducing the diameter of the proximal constraining loop 195and thus results in a collapsing or constraining force within theproximal constraining loop 195. In turn, release of the tension permitsthe proximal constraining loop 195 to expand.

In contrast to the described-configuration with the support portion 24,in some embodiments implementing the support portion 524, the distalconstraint 182 passes through and out of the third constraint lumen 58and into and through one of the passages 566 of the support guide 562(e.g., the second constraint passage 572). The distal constraint 182then passes outside of the proximal guide 582 and then into and throughone of the plurality of passages 612 of the intermediate guide 586(e.g., the second constraint passage 618) and then into and through oneof the plurality of passages 602 of the distal guide 584 (e.g., thesecond constraint passage 608) to extend radially away from the centrallongitudinal axis Xs of the support portion 524. The distal constraint182 loops about the support portion 524, crosses over itself, and issecured to the stake member 30 with the stake member 30 received throughthe catch 192 of the distal constraint 182 to define a distalconstraining loop 196. Proximally tensioning the distal constraint 182,for example with the second spindle 36 of the actuation portion 20 (FIG.2), causes the distal constraining loop 196 to constrict, and thusresults in a collapsing or constraining force within the distalconstraining loop 196 reducing a diameter of the distal constrainingloop 196. In turn, release of the tension permits the distalconstraining loop 196 to expand.

In contrast to the described-configuration with the support portion 24,in some embodiments implementing the support portion 524, theintermediate constraint 184 passes out of the first constraint lumen 54(FIG. 3) and passes into and through one of the passages 566 of thesupport guide 562 (e.g., the third constraint passage 574). Theintermediate constraint 184 then passes outside of the proximal guide582 to the intermediate guide 586 and into one of the plurality ofpassages 612 of the intermediate guide 586 (e.g., the first constraintpassage 616 as shown). The intermediate constraint 184 then extendsradially away from the central longitudinal axis Xs of the supportportion 524, then loops about the support portion 524, crosses overitself, and is secured to the stake member 30 with the stake member 30received through the catch 194 of the intermediate constraint 184 todefine an intermediate constraining loop 197. Proximally tensioning theintermediate constraint 184, for example with the third spindle 38 ofthe actuation portion 20 (FIG. 2), causes the intermediate constrainingloop 197 to constrict, and thus results in a collapsing or constrainingforce within the intermediate constraining loop 197 reducing a diameterof the intermediate constraining loop 197. In turn, release of thetension perm its the distal constraining loop 196 to expand.

Various methods of assembling and operating the transcatheter deliverysystem 10 are contemplated. Substantially the same methods areoptionally used, regardless of whether the support portion 24 or thesupport portion 524 is employed. Additionally, substantially the samemethods can be used for the transcatheter delivery system 510, oradditional example transcatheter delivery systems described below (e.g.,transcatheter delivery system 1010), to those methods of assembling andoperating described below.

In some examples, a method of assembling the transcatheter deliverysystem 10 includes arranging the prosthetic valve 16 on the supportportion 24 of the delivery catheter 14 such that the centrallongitudinal axis Xv of the prosthetic valve 16 is laterally offset fromthe central longitudinal axis Xs of the support portion 24 and a leafletregion 262 of the prosthetic valve 16 is located between the proximalguide 82 and the distal guide 84 of the support portion 24 as previouslydescribed. The method also includes compacting the prosthetic valve 16into a radially compressed delivery configuration such that the leafletregion 262 is received over the intermediate guide 86 and in between theproximal guide 82 and the distal guide 84. The proximal constraint 180,the distal constraint 182, and the intermediate constraint 184 aresecured around the prosthetic valve 16 and to the delivery catheter 14with the stake member 30 as previously described. The prosthetic valve16 is constrained in the radially compressed delivery configuration withthe proximal constraining loop 195 defined by the proximal constraint180, the distal constraining loop 196 defined by the distal constraint182, and the intermediate constraining loop 197 defined by theintermediate constraint 184. The prosthetic valve 16 in the compacted,delivery state, or configuration, can be received inside the sheath 12and then extended from the sheath 12 during a medical procedure fordelivering the prosthetic valve 16 into a body of a patient. Forreference, FIG. 17B shows the prosthetic valve 16 partially retractedinto the sheath 12.

Various methods of replacing a natural valve of in a body of a patientwith the transcatheter delivery system 10 are contemplated. Someexamples include positioning the prosthetic valve 16 at a desiredlocation in a patient using the transcatheter delivery system 10, wherethe prosthetic valve 16 is mounted on the support portion 24 of thetranscatheter delivery system 10 and maintained in a collapsed, deliveryconfiguration by the proximal constraining loop 195, the distalconstraining loop 196, and the intermediate constraining loop 197 aspreviously described. In some examples, the method includes releasingthe proximal constraining loop 195 by decreasing tension on the proximalconstraint 180 as previously described, such that the proximal portion200 of the prosthetic valve 16 self-expands, releasing the distalconstraining loop 196 by decreasing tension on the distal constraint 182as previously described, such that the distal portion 202 of theprosthetic valve 16 self-expands, and releasing the intermediateconstraining loop 197 by decreasing tension on the intermediateconstraint 184 as previously described, such that the intermediateportion 204 of the prosthetic valve 16 self-expands.

In some examples, the proximal constraining loop 195, the distalconstraining loop 196, and/or the intermediate constraining loop 197 arereleased concurrently. In some examples, the proximal constraining loop195, the distal constraining loop 196, and/or the intermediateconstraining loop 197 are released sequentially. Release of the proximalconstraining loop 195, the distal constraining loop 196, and theintermediate constraining loop 197 as previously described permits theprosthetic valve 16 to self-expand to an enlarged diameter as shown inFIG. 12. Following expansion, the stake member 30 is able to be slidproximally so that the catch 190 of the proximal constraint 180, thecatch 192 of the distal constraint 182, and the catch 194 of theintermediate constraint 184 are released. Then, according to someembodiments, the proximal constraint 180, the distal constraint 182, andthe intermediate constraint 184 can be tensioned and pulled from aroundthe prosthetic valve 16 and back to the delivery catheter 14 to releasethe proximal constraint 180, the distal constraint 182, and theintermediate constraint 184 from the prosthetic valve 16 and, thus, theprosthetic valve 16 from the delivery catheter 14.

In some other examples, the stake member 30 is additionally oralternatively releasably received through (e.g., threaded through) oneor more of the frame portion 210 and/or the cover 212 of the prostheticvalve 16 similarly to the plurality of constraints 28 to help secure theprosthetic valve 16 to the delivery catheter 14 prior to release fromthe delivery catheter 14. The prosthetic valve 16 is then optionallyreleased from the delivery catheter 14 by pulling the stake member 30out of the proximal guide 82, the distal guide 84, and the intermediateguide 86, as well as the portions of the prosthetic valve 16 into whichthe stake member 30 is threaded to release the prosthetic valve 16.

FIGS. 19 and 20 show partial side views of another transcatheterdelivery system 1010 having features and components that may be usedinterchangeably with any of the components of the transcatheter deliverysystem 10 (and vice versa). For ease of understanding, similar featuresas those of the transcatheter delivery system 10 are labeled for thetranscatheter delivery system 1010 with “1000” added to thecorresponding feature reference number. From the foregoing example, itshould be apparent that the transcatheter delivery system 10 can bemodified for use with an endoprosthesis, such as a stent graft, as shownin FIG. 20.

The transcatheter delivery system 1010 can include a sheath (not shown),such as sheath 12, a delivery catheter 1014, which can be similar todelivery catheter 14, and an implantable device 1016, which can be astent graft as shown in FIG. 20, or another implantable device, such asprosthetic valve 16, having one or more portions that are maintained ina collapsed configuration by the delivery catheter 1014. It should benoted that the sheath (not shown) or other features, such asconstraining sleeves or jackets (not shown), can additionally oralternatively be employed along one or more portions of the implantabledevice 1016 to assist with maintaining the implantable device 1016 in acollapsed configuration.

Similar to the delivery catheter 14, the delivery catheter 1014,includes an actuation portion (not shown), which can be similar toactuation portion 20, a body portion 1022, a support portion 1024, a tipportion 1026, one or more constraints 1028, which can be similar to theplurality of constraints 1028, and a stake member 1030, which can alsobe described as a lock wire and which can be similar to the stake member30. As shown, the transcatheter delivery system 1010 includes a singleconstraint 1028, although more are contemplated.

As shown, the support portion 1024 is generally configured to bereceived in the implantable device 1016 and to support the implantabledevice 1016 through delivery to, and deployment at a desired treatmentlocation in a body of a patient (not shown). As shown, the supportportion 1024 includes a shaft 1080, which can be similar to the shaft80, a proximal guide 1082, which can be similar to the proximal guide82, and a distal guide 1084, which can be similar to the distal guide84. As shown, the support portion 1024 does not include an intermediateguide, such as the intermediate guide 86, but such an option iscontemplated. The proximal guide 1082 optionally includes a taper, suchas an angled portion 1082 a that eases retraction of the proximal guide1082 into a sheath, such as sheath 12 (FIG. 1).

As shown, a first reduced profile section 1154 (e.g., similar to thefirst reduced profile section 154) is at a location that is intermediateor between the proximal guide 1082 and the distal guide 1084 and canprovide additional area for the implantable device 1016 and/or assistwith ensuring that the stake member 1030 has sufficient bending strengthto facilitate anchoring the constraint 1028 to the stake member 1030while tensioning the constraint 1028 in a similar manner to theplurality of constraints 28.

As shown in FIG. 20, similarly to the plurality of constraints 28, theconstraint 1028 is received through portions of the implantable device1016 (e.g., through a distal row of closed cells 1250 at a distal end1220 of a frame portion 1210 of the implantable device 1016). As shown,the constraint 1028 is optionally routed in an “under the frame”configuration in which the constraint 1028 are routed under the frameportion 1210 of the implantable device 1016. In some examples, thisrouting pattern can help reduce the frictional forces encountered by theconstraint 1028 and facilitate reduced tensioning forces used with theconstraint 1028.

Although not treated in further detail, it should be readily understoodthat operation of the transcatheter delivery system 1010 and theconstituent components for such operation can be taken from any of theexamples and options described in association with the transcatheterdelivery system 10, and vice versa.

FIG. 21A is a side view of a transcatheter delivery system 3500 includesa delivery catheter 3510 for delivering and deploying a multi-frameimplantable device 3000. The multi-frame implantable device 3000 isshown including an outer frame 3100, an inner frame 3200 longitudinallyoffset from, and optionally nestable within the outer frame followingdelivery, and a flexible interconnection 3300 between the outer frame3100 and the inner frame 3200 that is invertible upon nesting the innerframe within the outer frame, although this is an example only andnesting need not be present in all examples. In some examples, themulti-frame implantable device is a prosthetic valve configured for usein repairing or replacing a mitral valve, although a variety ofimplantable devices are contemplated. The inner frame 3200 is optionallya leaflet frame (i.e., is configured to support a leaflet construct) andthe outer frame 3200 is optionally a reinforcing frame (e.g., beingconfigured to reinforce or otherwise support the inner frame). In otherexamples, the inner frame serves as a reinforcing frame and the outerframe serves as a leaflet frame.

In a similar manner to previously described examples (e.g., deliverycatheter 14), the delivery catheter 3510 includes a body portion 3510, asupport portion 3512, a tip portion 3514, and one or more constraints,such as a first pair of constraints 3536 and a second pair ofconstraints 3538, wherein the first pair of constraints 3536 areassociated with the first pair of guides 3522 and wherein the secondpair of constraints 3538 are associated with the second pair of guides3524.

In various examples, each pair of constraints is adapted and arranged tointerface with a respective one of the outer frame 3100 and the innerframe 3200. The first pair of constraints 3536 generally includes aproximal constraint 3540 and a distal constraint 3542. It will beappreciated that the first pair of constraints 3536 may additionallyinclude an intermediate constraint situated between the proximal anddistal constraints 3540 and 3542, as desired, though one is notillustrated. The body portion 3510 defines a central longitudinal axisXa and has a proximal section (not shown, but which may be similar toother examples, such as the proximal section 40) and a distal section3520. The body portion 3510 is of suitable length for a user (not shown)to manipulate the delivery device 3500 from a location outside the bodyof a patient into which the implantable device (not shown in FIG. 21A)is being implanted. Generally, the body portion 3510 is of sufficientflexibility, length, and column strength such that it is suitable fortraversing the vasculature or other bodily lumens and conduits within apatient.

FIG. 21B is a sectional view taken along line B-B in FIG. 21A, accordingto some embodiments. As shown in FIG. 21B, the body portion 3510 has aplurality of lumens 3511 extending within the body portion 3510, whichcan also be described as passages or channels. In the same manner asprior examples, the plurality of lumens 3511 extend the length of thebody portion 3510 through the proximal and distal sections of thedelivery catheter. In some embodiments, the lumens 3511 include two ormore stake member lumens, such as first stake member lumen 3513 andsecond stake member lumen 3515. Additionally, in some embodiments thelumens 3511 include a first constraint lumen 3517, a second constraintlumen 3519, a third constraint lumen 3521, and a fourth constraint lumen3523, although a number of additional lumens (e.g., eight, ten, twelve,etc.), are contemplated. In some embodiments, the lumens 3511 furtherinclude a central lumen 3525. In various examples, the first and secondstake member lumens 3513 and 3515, as well as the first constraint lumen3517, the second constraint lumen 3519, the third constraint lumen 3521,and the fourth constraint lumen 3523 are each optionally located at adesired angular position about the central longitudinal axis Xa of thebody portion 3510.

As shown, the first stake member lumen 3513 is at a positioncorresponding to 12 o'clock or 0 degrees, the second stake member lumen3515 is at a position corresponding to 2 o'clock, or 60 degrees, thefirst constraint lumen 3517 is at a position corresponding to 4 o'clockor 120 degrees, the second constraint lumen 3519 is at a positioncorresponding to 6 o'clock or 180 degrees, the third constraint lumen3521 is at a position corresponding to 8 o'clock or 240 degrees, and thefourth constraint lumen 3523 is at a position corresponding to 10o'clock, or 270 degrees. Though some examples of angular positions areprovided, any number of positions can be employed as desired. As shown,the central lumen 3525 may be positioned coaxially with the longitudinalaxis Xa of the body portion 3510, although, again, any number ofpositions can be employed as desired.

The distal section 3520 of the body portion 3510 is coupled to thesupport portion 3512 and optionally includes one or more features forassisting with passing the distal section 3520 into, out of, and/orthrough a constraining sheath. For example, the distal section mayinclude a flare, flange, or taper, to provide an increased diametricprofile to the distal section 3520 adjacent the support portion 3512.This increased diametric profile, also described as an outer transverseprofile, has a relatively smooth transition to reduce snagging ormechanical friction between a constraining sheath and the distal section3520 when the distal section 3520 is slid through, extended from, and/orretracted into such a constraining sheath and through the vasculature orother conduits within a patient (not shown).

The support portion 3512 is generally configured to be received in theimplantable device 3000 and to support the implantable device 3000through delivery to, and deployment at a desired treatment location in abody of a patient (not shown). As shown, the support portion 3512extends from the distal section 3520 of the body portion 3510 and has acentral longitudinal axis Xb. In various examples, the centrallongitudinal axis Xb of the support portion 3512 is parallel with thecentral longitudinal axis Xa of the body portion 3510. In some examples,the central longitudinal axis Xb is coaxial with the centrallongitudinal axis Xa. The support portion 3512 includes a shaft 3526. Insome examples, the shaft 3526 supports the one or more constraints ofthe plurality of constraints 3516. The shaft 3526 may be generally thesame as include similar features to those of the shaft 80 that have beenpreviously or are subsequently described (e.g., including an enhancedflexibility portion). In various embodiments, the shaft 3526 is aflexible elongate element and may optionally include a central lumen,such as for receiving a guidewire, as those of skill will appreciate.

In various examples, the support potion 3512 further includes a firstpair of guides 3522 and a second pair of guides 3524, as discussedfurther below.

In various embodiments, the shaft 3526 is formed as a hollow tube (e.g.,hypotube), for example using nitinol, stainless steel, or other metallicor polymeric materials. In various examples, the shaft 3526 isconfigured to receive a guidewire (not shown) for guiding the deliverydevice 3500 to a desired treatment location within the patient'sanatomy. If desired, however, the shaft 3526 may also be formed as asolid member without any internal lumen. The shaft 3526 is optionallycoupled to the tip portion 3514 (e.g., inserted into and press-fit orbonded to the tip portion 3514), extends a length of the support portion3512, and is coupled to the body portion 3510 (e.g., extending throughthe central lumen 3525 and out of the proximal end of the body portion3510). The shaft 3526 is optionally a single, unitary member, thoughseparate connected components are also contemplated.

In various examples, each pair of guides 3522 and 3524 is adapted andarranged to interface with one or more of the constraints 3516. Thefirst pair of guides 3522 generally includes a proximal guide 3528 and adistal guide 3530. It will be appreciated that the first pair of guides3522 may additionally include an intermediate guide situated between theproximal and distal guides 3528 and 3530, as desired, though one is notillustrated. In some examples, the second pair of guides 3524 generallyincludes a proximal guide 3532 and a distal guide 3534. It will beappreciated that the second pair of guides 3524 may likewiseadditionally include an intermediate guide situated between the proximaland distal guides 3532 and 3534 as desired.

As shown in FIGS. 21C and 21D, the proximal and distal guides 3528 and3530 of the first pair of guides 3522 are generally cylindrical overall,having transverse outer profiles that are cylindrical, which alsocorresponds to a transverse outer profile that is circular in transversecross-section. It will be appreciated that although cylindrical profilesare contemplated, any of a variety of tapers, steps, chamfers and otherfeatures is also contemplated. In some examples the proximal and distalguides 3528 and 3530 are configured to support the inner frame 3200.

In various examples, each of the proximal and distal guides 3528 and3530 of the first pair of guides 3522 defines a central longitudinalaxis (not separately labeled) that is coaxial with the centrallongitudinal axis Xa of the support portion 3512 and by transitivetheory, the central longitudinal axis of the shaft 3526, according tosome examples.

As shown in FIG. 21C, in some embodiments, the proximal guide 3528includes a central lumen 3527 through which the shaft 3526 is received,for coupling the proximal guide 3528 to the shaft 3526. As shown, theproximal guide 3528 also includes a plurality of passages 3529, alsodescribed as channels or lumens. In various examples, the plurality ofpassages 3529 includes one or more stake member passages, such as firststake member passage 3533 and second stake member passage 3535.Additionally, in some embodiments the passages 3529 include a firstconstraint passage 3537, a second constraint passage 3539, a thirdconstraint passage 3541, and a fourth constraint passage 3543, althougha number of additional passages (e.g., eight, ten, twelve, etc.), arecontemplated. In various examples, the first and second stake memberpassages 3533 and 3535, as well as the first constraint passage 3537,the second constraint passage 3539, the third constraint passage 3541,and the fourth constraint passage 3543 are each optionally located at adesired angular position about the central longitudinal axis Xb of thesupport portion 3512.

As shown, the stake member passages and the constraint member passagescorrespond in angle and in offset with the stake member lumens and theconstraint member lumens of the body portion 3510, discussed above. Forexample, the first stake member passage 3533 corresponds with the firststake member lumen 3513 in that the first stake member passage 3533 isat an angular position corresponding to 12 o'clock or 0 degrees.

As seen with reference between FIGS. 21C and 21D, the distal guide 3530is substantially similar to the proximal guide 3528. In some examples,the distal guide 3530 is also cylindrical overall, having a transverseouter profile that is cylindrical, which also corresponds to atransverse outer profile that is circular in transverse cross-section,although any of a variety of tapers, steps, chamfers and other featuresare also contemplated, as mentioned above.

The distal guide 3530 also defines a central longitudinal axis (notseparately labeled) that is coaxial with the central longitudinal axisXa of the support portion 3512 and by transitive theory, the centrallongitudinal axis of the shaft 3526 (as well as the proximal guide3528), according to some examples.

As shown in FIG. 21D, in some embodiments, the distal guide 3530includes a central lumen 3545 through which the shaft 3526 is received,for coupling the distal guide 3530 to the shaft 3526. As shown, thedistal guide 3530 also includes a plurality of passages 3547, alsodescribed as channels or lumens. In various examples, the plurality ofpassages 3547 include one or more stake member passages, such as firststake member passage 3553 and second stake member passage 3555.Additionally, in some embodiments the passages 3547 include a firstconstraint passage 3557, a second constraint passage 3559, a thirdconstraint passage 3561, and a fourth constraint passage 3563, althougha number of additional passages (e.g., eight, ten, twelve, etc.), arecontemplated. In various examples, the first and second stake memberpassages 3553 and 3555, as well as the first constraint passage 3557,the second constraint passage 3559, the third constraint passage 3561,and the fourth constraint passage 3563 are each optionally located at adesired angular position about the central longitudinal axis Xb of thesupport portion 3512.

As shown, the stake member passages and the constraint member passagescorrespond in angle and in offset with the stake member lumens and theconstraint member passages of the proximal guide 3528, discussed above.For example, the first stake member passage 3553 corresponds with thefirst stake member passage 3533 in that the first stake member passage3553 is at an angular position corresponding to 12 o'clock or 0 degrees.

In various embodiments, each of the passages 3529 of the proximal guide3528 is aligned with a corresponding passage of the plurality ofpassages 3547 of the distal guide 3530. In other words, the first stakemember passage 3533 is angularly aligned with the first stake memberpassage 3553, and the first constraint passage 3537 with the firstconstraint passage 3557, etc., as mentioned above. It will beappreciated, however, that one or more of the plurality of passages 3529and the plurality of passages 3547 may be angularly misaligned, or outof alignment with one another. Moreover, the distal guide 3530 need nothave the same number of passages as the proximal guide 3528, asdiscussed below.

As shown in FIGS. 21E and 21F, the proximal and distal guides 3532 and3534 of the second pair of guides 3524 are generally cylindricaloverall, having transverse outer profiles that are cylindrical, whichalso corresponds to a transverse outer profile that is circular intransverse cross-section. It will be appreciated that althoughcylindrical profiles are contemplated, any of a variety of tapers,steps, chamfers and other features is also contemplated. In someexamples, a diameter of the proximal and distal guides 3532 and 3534 ofthe second pair of guides 3524 is generally less than a diameter of theproximal and distal guides 3528 and 3530 of the second pair of guides3524. In some examples such a configuration provides that the innerframe 3200 can be proximally retracted (e.g., telescoped) into aninterior region defined by the outer frame 3100. That is, by providingproximal and distal guides 3532 and 3534 that have a smaller diameter,the inner frame 3200 can be reduced to a smaller cross sections suitablefor being received within the outer frame 3100. In some examples theproximal and distal guides 3532 and 3534 are configured to support theinner frame 3200.

In various examples, each of the proximal and distal guides 3532 and3534 of the second pair of guides 3524 defines a central longitudinalaxis (not separately labeled) that is coaxial with the centrallongitudinal axis Xa of the support portion 3512 and by transitivetheory, the central longitudinal axis of the shaft 3526, according tosome examples.

As shown in FIG. 21E, in some embodiments, the proximal guide 3532includes a central lumen 3565 through which the shaft 3526 is received,for coupling the proximal guide 3532 to the shaft 3526. As shown, theproximal guide 3532 also includes a plurality of passages 3567, alsodescribed as channels or lumens. In various examples, the plurality ofpassages 3567 include second stake member passage 3575, a firstconstraint passage 3577, and a second constraint passage 3579, althougha number of additional passages (e.g., eight, ten, twelve, etc.), arecontemplated. In various examples, the second stake member passage 3575,as well as the first constraint passage 3577 and the second constraintpassage 3579, are each optionally located at a desired angular positionabout the central longitudinal axis Xb of the support portion 3512.

As shown, the stake member passage and the constraint member passagescorrespond in angle and in offset with the stake member passages and theconstraint member passages of the distal guide 3530, discussed above.For example, the second stake member passage 3575 corresponds with thesecond stake member passage 3555 in that the second stake member passage3575 is at an angular position corresponding to 2 o'clock or 60 degrees.

As seen with reference between FIGS. 21E and 21F, the distal guide 3534is substantially similar to the proximal guide 3532. In some examples,the distal guide 3534 is also cylindrical overall, having a transverseouter profile that is cylindrical, which also corresponds to atransverse outer profile that is circular in transverse cross-section,although any of a variety of tapers, steps, chamfers and other featuresare also contemplated, as mentioned above.

The distal guide 3534 also defines a central longitudinal axis (notseparately labeled) that is coaxial with the central longitudinal axisXa of the support portion 3512 and by transitive theory, the centrallongitudinal axis of the shaft 3526 (as well as the proximal guide3532), according to some examples.

As shown in FIG. 21F, in some embodiments, the distal guide 3534includes a central lumen 3581 through which the shaft 3526 is received,for coupling the distal guide 3534 to the shaft 3526. As shown, thedistal guide 3534 also includes a plurality of passages 3583, alsodescribed as channels or lumens. In various examples, the plurality ofpassages 3583 include second stake member passage 3585, a firstconstraint passage 3587, and a second constraint passage 3589, althougha number of additional passages (e.g., eight, ten, twelve, etc.), arecontemplated. In various examples, the second stake member passage 3585,as well as the first constraint passage 3587 and the second constraintpassage 3589, are each optionally located at a desired angular positionabout the central longitudinal axis Xb of the support portion 3512.

As shown, the stake member passage and the constraint member passagescorrespond in angle and in offset with the stake member passages and theconstraint member passages of the proximal guide 3532, discussed above.For example, the second stake member passage 3585 corresponds with thesecond stake member passage 3575 in that the second stake member passage3585 is at an angular position corresponding to 2 o'clock or 60 degrees.

As shown in FIG. 21A, the plurality of constraints 3516 comprises afirst pair of constraints 3536 and a second pair of constraints 3538,wherein the first pair of constraints 3536 are associated with the firstpair of guides 3522 and wherein the second pair of constraints 3538 areassociated with the second pair of guides 3524. In various examples,each pair of constraints is adapted and arranged to interface with arespective one of the outer frame 3100 and the inner frame 3200. Thefirst pair of constraints 3536 generally includes a proximal constraint3540 and a distal constraint 3542. It will be appreciated that the firstpair of constraints 3536 may additionally include an intermediateconstraint situated between the proximal and distal constraints 3540 and3542, as desired, though one is not illustrated. The second pair ofconstraints 3538 generally includes a proximal constraint 3544 and adistal constraint 3546. It will be appreciated that the second pair ofconstraints 3538 may likewise additionally include an intermediateconstraint situated between the proximal and distal constraints 3544 and3546, as desired, though one is not illustrated.

In some embodiments, each of the plurality of constraints 3516 is formedas a fiber, strand, wire, combinations thereof or the like, and may bebraided, wound, extruded, or otherwise formed of metallic or polymericmaterials. For example, each of the constraints 3516 may be formed frombraided strands of material, such as UHMWPE or ePTFE. Although three areshown, any number of constraints (e.g., one, two, four, nine, etc.) arecontemplated. In some embodiments, the proximal constraint 3540 includesa catch 3548 in the form of a terminal, closed loop or eyelet, forexample. The catch 3548 is optionally formed using braiding methods(e.g., by twisting the braid into itself or through a continuousbraiding method that forks a single strand into two separates strandsand then rebraids them into a single strand to form an eyelet). Thedistal constraint 3542 similarly includes a catch 3550, as does theproximal constraint 3544, which includes catch 3552. Distal constraint3546 includes a catch 3554.

The transcatheter delivery system 3510 can include a sheath (not shown),such as sheath 12, a delivery catheter 3514, which can be similar todelivery catheter 14, and an implantable device, which can be a valve oranother implantable device having one or more portions that aremaintained in a collapsed configuration by the delivery catheter 3514.It should be noted that the sheath (not shown) or other features, suchas constraining sleeves or jackets (not shown), can additionally oralternatively be employed along one or more portions of the implantabledevice (not shown) to assist with maintaining the implantable device ina collapsed configuration. The delivery catheter 3514 also includes twoor more stake members, which can also be described as a lock wire andwhich can each be similar to the stake member 30.

In various examples, the stake members include a first stake member 3556and a second stake member 3558. The first stake member 3556 is generallyassociated with securing or otherwise engaging with the first pair ofconstraints (not shown) and the first pair of guides 3522, while thesecond stake member 3558 is generally associated with securing orotherwise engaging with the second pair of constraints (not shown) andthe second pair of guides 3084. For example, as shown in FIG. 21G, thefirst stake member 3556 extends through first stake member lumen 3513 ofthe body portion 3510 and into the first stake member passages 3533 and3553 of proximal and distal guides 3528 and 3530 of the first pair ofguides 3522. Likewise, as shown in FIG. 21G, the second stake member3558 extends through second stake member lumen 3515 of the body portion3510, through second stake member passages 3535 and 3555 of the proximaland distal guides 3528 and 3530 of the first pair of guides 3522, andinto the second stake member passages 3575 and 3585 of the proximal anddistal guides 3532 and 3530 of the second pair of guides 3524.

Turing now to FIG. 21H, a nonlimiting delivery operation in accordancewith the above discussed examples and embodiments is illustrated anddescribed. As shown, the first pair of constraints 3536 (e.g., proximaland distal constraints 3540 and 3542) has been released from the firststake member 3556 such that the outer frame 1100 is operable to expandand engage a valve annulus of a mitral valve, for example. However, asshown, proximal and distal constraints 3544 and 3546 remain coupled withsecond stake member 3558 and the leaflet frame 3200.

Though not illustrated as such in FIG. 21H, it will be understood thatin actuality, each of the proximal and distal constraints 3544 and 3546are coupled (e.g., woven or otherwise passed through) portions of theinner frame 3200.

With the outer frame 3100 unconstrained and the leaflet frame 3200 atleast partially constrained by one or more of the proximal and distalconstraints 3544 and 3546, the delivery device 3500 can be proximallywithdrawn in the direction of arrow 3560 (e.g., proximally translated)relative to the valve annulus and the outer frame 3100 such that theinner frame 3200 is proximally withdrawn into the interior regiondefined by the outer frame 3100, as discussed herein. In variousexamples, the delivery device 3500 is proximally withdrawn until theinner frame 3200 becomes nested within the outer frame 3100, asdiscussed herein.

In some examples, after releasing the first pair of constraints 3536from the first stake member 3556 and the outer frame 1100, and beforeproximally withdrawing the delivery device 3500 and the inner frame3200, a tension in one or more of the proximal and distal constraints3544 and 3546 may be reduced, thereby enabling one or more of the innerframe 3200 to partially deploy. Thus, in such examples, the deliverydevice 3500 is operable to partially deploy the inner frame 3200 priorto proximally withdrawing the delivery device 3500 and the inner frame3200.

It should be appreciated that while the above discussed examples andembodiments include a delivery system including a plurality of stakemembers, the delivery system may be operable with a single stake member.For instance, in some examples the stake member may engage and retaineach of a first constraint extending about the outer frame 3100 and asecond constraint extending about the inner frame 3200. In such examplesthe stake member is generally routed through one or more guides suchthat proximally retracting proximal end of the stake member results in adistal end of the stake member advancing proximally along the supportportion of the delivery system such that the constraint extending aboutthe outer frame 1100 can be released prior to releasing the constraintextending about the leaflet frame 1200.

FIGS. 22A-22D show additional design concepts for the proximal guide 82,the distal guide 84, and/or the intermediate guide 86, as well as theproximal guide 1082 and/or the distal guide 1084, in the form of a guide2082. In various examples, the guide 2082 includes a filament formedinto at least one loop adapted to wrap around and couple to an outercircumference of a shaft 2080 (e.g., support portion) and to define atleast one constraint passage between the shaft 2080 and the filament.Similar to the previously-described guide designs, the constraintpassage of the guide 2082 is configured to receive a constraint (e.g., afiber) that extends longitudinally through the constraint passage and isthen directed transversely/radially outward to form a releasable, loopedconfiguration to define a constraining loop (e.g., the proximalconstraining loop 195). In various examples, the looped filament designfor the guide 2082 can help provide ease of manufacturability, a reducedoverall guide profile for a higher level of diametric compaction of adevice over the guide, and resistance to deflection of the stake memberwhen placed under load by the constraint (e.g., when the constraint istensioned).

FIG. 22A is a perspective view of the guide 2082 mounted on a section ofa shaft 2080 (e.g., support portion 24 of shaft 80 or support portion1024 of shaft 1080) of a transcatheter delivery system (e.g., thetranscatheter delivery system 10 or the transcatheter delivery system1010).

FIG. 22B is a bottom view of the guide 2082 as mounted on the shaft2080. As shown, the guide 2082 includes one or more turns of a filament(e.g., a wire, fiber, braid, bead, or hypotube) wrapped or otherwisedisposed around the shaft 80. In various examples, the filament formingany of the guides resiliently retain their shape, although lessresilient, more flexible filaments may be employed as desired.

FIG. 22C is an end view of the guide 2082, according to someembodiments. As shown, the guide 2082 defines a central longitudinalaxis (not separately labeled) that is coaxial with the centrallongitudinal axis of the shaft 2080, according to some examples. Asshown, the guide 2082 includes a central lumen 2088 through which theshaft 2080 is received, for coupling the guide 2082 to the shaft 2080.

As shown in FIGS. 22A and 22B, the guide 2082 defines a plurality ofturns, or revolutions around the shaft 2080, including a first base turn2090 (also described as a securing loop), a first eyelet turn 2092 (alsodescribed as a guide loop), second eyelet turn 2094 (also described as aguide loop), and a second base turn 2096 (also described as a securingloop), although any number of revolutions, turns, rings, loops, orpasses around the shaft 2080 are contemplated. Though the guide 2082 isshown as a single, continuous length of material extending about theguide 2082 multiple times along a helical path, or other longitudinaland circumferential path, in other examples separate turns (e.g.,separate rings or loops) are also contemplated for each of the turns2090, 2092, 2094, 2096. As shown, the first base turn 2090 and thesecond base turn 2096 are each cylindrical overall and may be relativelytightly engaged to the outer circumference of the shaft 80 (e.g., tohelp secure the guide 2082 to the shaft 2080).

The first eyelet turn 2092 has an eccentric profile relative to theshaft 2080 and defines a stake member passage 2092A, also described as astake member passage 2092A. The second eyelet turn 2094 has an eccentricprofile relative to the shaft 2080 and defines a constraint passage2094A. The stake member passage 2092A is configured to receive a stakemember, such as the stake member 30 or the stake member 1030 similarlyto stake member passages of any of the proximal, intermediate, or distalguides previously described. The constraint passage 2094A is configuredto receive a constraint, such as one of the plurality of constraints 28or one of the plurality of constraints 1028, similarly to constraintpassages of any of the proximal, intermediate, or distal guidespreviously described.

The stake member passage 2092A and the constraint passage 2094A are eachoptionally located at a desired angular position about the centrallongitudinal axis of the shaft 2080. For example, the stake memberpassage 2092A and the constraint passage 2094A are optionally located atthe same angular location, and serve a similar function, to the stakemember passage 92 and the first constraint passage 94, respectively, ofthe transcatheter delivery system 10 or similar features of thetranscatheter delivery system 1010.

As shown, the stake member passage 2092A is at an angular positioncorresponding to 12 o'clock or 0 degrees and the constraint passage2094A is at an angular position corresponding to 11 o'clock, or −15degrees. Though some examples of angular positions are provided, anynumber of angular positions can be employed as desired.

The guide 2082 has a maximum transverse outer profile at one or moretransverse cross-sections along the length of the guide 20882 and aminimum transverse outer profile at one or more transversecross-sections along the length of the guide 2082. For example, theguide 2082 optionally defines a maximum transverse outer profile at thefirst eyelet turn 2092 and/or the second eyelet turn 2094, and a minimumtransverse outer profile at the first base turn 2090 and/or at thesecond base turn 2096, although any of a variety of outer profiles arecontemplated, including tapers, steps, chamfers and other features.Generally, the arrangement of the first eyelet turn 2092 and the secondeyelet turn 2094 is selected to minimize overall profile, thus helpingto facilitate maximum diametric compaction of a device around the guide2082.

The configuration associated with the guide 2082 can be employed for theproximal guide 82 and/or the intermediate guide 86 as desired. Forexample, a second guide of the same or similar design to that of theguide 2082 can be implemented such that both the proximal guide 82 andthe intermediate guide 86 have a design corresponding to the design ofthe guide 2082. In use, where a design such as that shown in FIG. 22C isutilized for the proximal guide 82 of the transcatheter delivery system10, rather than passing through a second constraint passage, such as thesecond constraint passage 96, the distal constraint 182 may simplybypass, or extend next to the guide 2082, extending alongside the stakemember passage 2092A.

FIG. 22D shows an end view of a variation of the guide 2082, where theposition of the stake member passage 2092A is at a similar angularposition to that shown in FIG. 22C, but the constraint passage 2094A isat an angular position corresponding to 1 o'clock, or +15 degrees.Though some examples of angular positions are provided, any number ofangular positions can be employed as desired. The arrangement shown inFIG. 22D can be employed as a replacement for that previously describedfor the distal guide 84 of the transcatheter delivery system 10. Theconstraint passage 2094A as shown in FIG. 22D is optionally employed ina similar manner as the second constraint passage 108 of the distalguide 84.

The guide 2082 is optionally formed and attached to the shaft 2080 usingany of a variety of methods, including wrapping or winding a filament(e.g., wire) around the shaft 2080 with sufficient tension such that theguide 2082 remains at a desired location with a desired orientation onthe shaft 2080. If desired, heat treatments, adhesives, or other methodsmay be employed to facilitate securing the guide 2082 to the shaft.Additionally, the guide 2082 can be formed separately from the shaft2080 with an inner diameter smaller than the outer diameter of the shaft2080, and then be expanded, placed over the shaft, and allowed to recoilsuch that a bias/spring force assists with coupling the guide 2082 andshaft 2080. Multiple guides like the guide 2082 may be attached to theshaft 2080 using any of these techniques. The guide 2082 may be formedof any of a variety of metallic or polymeric materials, including shapememory materials, nickel titanium alloys, stainless steel alloys,fluoropolymers, and others.

FIGS. 22A-22F show more design concepts for the proximal guide 82, thedistal guide 84, and/or the intermediate guide 86, as well as theproximal guide 1082 and/or the distal guide 1084, in the form of a guide2182.

In the examples shown, the guide 2182 is generally described inassociation with use in place of the proximal guide 82 of thetranscatheter delivery system 10. From this example, it should bereadily understood that any of the proximal, intermediate or distalguides previously described in association with the transcatheterdelivery system 10 or transcatheter delivery system 1010 may beconfigured in the same or similar manner as the guide 2182. As with theother guide configurations, the guide 2182 is configured to receive aconstraint (e.g., the proximal constraint 180 as shown in FIG. 23B) thatextends longitudinally through the constraint passage and is thenredirected transversely/radially outward by the guide 2182 to form areleasable, looped configuration to define a constraining loop (e.g.,the proximal constraining loop 195 as shown in FIGS. 23A-23C).

FIG. 23A shows an area where the guide 2182 (hidden in FIG. 23A) couldbe located with regard to the transcatheter delivery system 10 (e.g., asa proximal guide located under the prosthetic valve 16 for maintainingthe proximal constraining loop 195). FIG. 23B is the same arrangement as22A, but from a reverse angle. FIG. 23C shows the guide 2182 with theprosthetic valve 16 not shown for ease of visualization of theinteraction between the guide 2182 and the proximal constraining loop195 and the guide 2182 and the stake member 30 in use.

FIG. 23D is a top view of the region of the support portion 24 proximatethe guide 2182. FIG. 23E is an end view of the support portion 24proximate the guide 2182 showing the distal section 42 of the bodyportion 22, and FIG. 23F is a side view of approximately the same regionas FIG. 23D. In FIG. 23E, the transverse angular position relative tothe top of the support portion 24 corresponding to “12 o'clock” islabeled for ease of reference. For reference, the proximal constraint180 is not shown in FIGS. 23D-23F for ease of visualization.

As shown, the guide 2182 includes a fiber guide tube 2192 and optionallyincludes a stake guide tube 2193, which can also be described as a lockwire guide tube 2193. The fiber guide tube 2192 and the stake guide tube2193 are optionally formed separately and located proximate one anotheras shown. Each of the fiber guide tube 2192 and the stake guide tube2193 is optionally individually formed as a continuous tubular member,such as a hypotube. The fiber guide tube 2192 and the stake guide tube2193 are optionally formed of similar or dissimilar materials asdesired, including any of a variety of metallic or polymeric materials.In some examples, the fiber guide tube 2192 and the stake guide tube2193 are formed of hypotube material. The fiber guide tube 2192 and thestake guide tube 2193 may be formed integrally with the shaft 80, or maybe separate formed and coupled to the shaft 80 using any of a variety offastening mechanisms, including welding, adhesives, fasteners, orothers.

As shown, the fiber guide tube 2192 includes a receiving portion 2194, atransition portion 2196, and a take-off portion 2198, where thereceiving portion 2194 is located proximal to the take-off portion 2198,and the transition portion 2196 is located between the receiving portion2194 and the take-off portion 2198 along the shaft 80. As shown, thereceiving portion 2194 extends along the outer circumference, or surfaceof the shaft 80 at a first transverse angular position relative to thetop of the support portion 24, and extends at a first, longitudinalangle relative to the longitudinal axis of the shaft 80 and the supportportion 24. For example, the receiving portion 2194 optionally extendsat a first longitudinal angle at, or close to zero degrees (plus orminus 15 degrees) as measured relative to the longitudinal axis of theshaft 80. The receiving portion 2194 is located at a first transverseangular position about the outer surface of the shaft 80. For example,the receiving portion 2194 is optionally at a first transverse angularposition of zero degrees, or 6 o'clock relative to a coordinate systemin which the top of the shaft 80 is at zero degrees, or 12 o'clock.

The transition portion 2196 of the fiber guide tube 2192 extends, orwraps around a portion of the outer circumference of the shaft 80, andthus the support portion 24, in a longitudinal and circumferentialfashion (e.g., helically substantially helically, or otherwisecurving/extending along the surface of the support portion 24), changingthe longitudinal angle and transverse angular position of the fiberguide tube 2192 between the receiving portion 2194 and the take-offportion 2198.

The take-off portion 2198 extends along the outer circumference, orsurface of the shaft 80 at a second transverse angular position, andextends at a second longitudinal angle. For example, the take-offportion 2198 is optionally at a second longitudinal angle at, or closeto 90 degrees (plus or minus 15 degrees) as measured relative to thelongitudinal axis of the shaft 80. The take-off portion 2198 is locatedat a second transverse angular position about the outer surface of theshaft 80 of 135 degrees, or 9 o'clock relative to a coordinate system inwhich the top of the shaft 80 is zero degrees, or 12 o'clock.

In some examples, the first longitudinal angle and the secondlongitudinal angle are offset by 45 degrees or more, such as by 90degrees, and the first transverse angular position and the secondtransverse angular position are offset by 45 degrees or more, such as by90 degrees.

In operational terms, the fiber guide tube 2192 is configured to receivea constraint (e.g., the proximal constraint 180) at a first longitudinalangle of extension (e.g., at or close to the first longitudinal angle ofthe receiving portion 2194) at the first transverse angular positionabout the circumference of the shaft 80. The fiber guide tube 2192 thenguides, or transitions the direction of extension of the constraint to asecond longitudinal angle of extension corresponding to the secondlongitudinal angle of the take-off portion 2198 at the second transverseangular position about the circumference of the shaft 80.

In some examples, the first longitudinal angle of extension and thesecond longitudinal angle of extension of the constraint as it passesthrough the fiber guide tube 2192 are offset from one another by 45degrees or more, such as by 90 degrees, and similarly the firsttransverse angular position and the second transverse angular positionare offset by 45 degrees or more, such as by 90 degrees.

In the example of FIGS. 22C-22F, the fiber guide tube 2192 is configuredto receive a constraint in a generally longitudinally extendingdirection with a first longitudinal angle of extension of zero or within15 degrees of zero, at a first transverse angular position correspondingto 90 degrees or 6 o'clock. The fiber guide tube 2192 transitions, orguides the direction of extension of the constraint to a generallyperpendicularly extending direction, at a second longitudinal angle ofextension of 90 degrees, or within 15 degrees thereof, at a secondtransverse angular position corresponding to 135 degrees or 9 o'clock.However, the fiber guide tube 2192 can be readily modified to provideany of a variety changes in longitudinal angles of extension andtransverse angular positions to a constraint (e.g., the proximalconstraint 180) as the constraint passes through the fiber guide tube2192.

In some examples, the take-off portion 2198 defines an outlet 2198A ofthe fiber guide tube 2192 which is outwardly flared. The outward flaredconfiguration can assist with avoiding chafing and facilitating smoothactuation of a constraint passing through the fiber guide tube 2192.Similarly, the receiving portion 2194 optionally defines an inlet 2194Aof the fiber guide tube 2192 which is outwardly flared. Again, theoutward flared configuration of the inlet 2194A can assist with avoidingchafing and facilitating smooth actuation of a constraint passingthrough the fiber guide tube 2192.

The stake guide tube 2193 similarly extends along the outercircumference, or surface of the shaft 80 at a desired transverseangular position and extends at a desired longitudinal angle. In theexample shown, the transverse angular position is zero degrees or 12o'clock and the longitudinal angle is zero degrees, although a varietyof transverse angular positions and longitudinal angles arecontemplated. As with the stake member passages of the guides previouslydescribed (e.g., stake member passage 92 of the proximal guide 82, thestake guide tube 2193 is configured to receive the stake member 30, andwill generally be positioned at a location to do so.

As shown in FIG. 23D, the stake guide tube 2193 is optionally distallyoffset from the fiber guide tube 2192 a desired amount (e.g., between 1mm and 10 mm), which can help avoid overlapping or self-interference ofthe constraint (e.g., the proximal constraint 180) as it forms aconstraining loop (e.g., the proximal constraining loop 195). Theoperation of the proximal, distal, and intermediate guide examplespreviously provided applies equally to the guide 2182, and it should beunderstood the configuration of FIGS. 23A-23F is optionally employed asan alternative the configurations previously described.

FIGS. 24A-24C and 24 show various options for one or more of theplurality of constraints 28, according to some embodiments. As shown,one of the plurality of constraints 28 may be secured in a loopedfashion (e.g., into an eye splice) to form a catch 28A (e.g., such asthe catch 190). FIG. 24A shows an example of an eye splice where a firstnumber of strands have been looped back and braided into themselves,FIG. 24B shows another example with a greater number of strands thathave been looped back and braided into themselves, and FIG. 24C showsstill another example where the catch 28A is formed via a continuousbraiding method that forks a single strand into two separates strandsand then re-braids them into a single strand to form the catch 28A wherethe strand has been separated. As shown in FIG. 25, with the examples ofFIGS. 24A and 24B, the catch 28A is optionally formed using an eyesplice method in which a desired length of the respective one of theplurality of constraints 28 is re-braided, or “buried,” into itself toform a buried length 28B of material. As previously referenced, theconstraint 1028 may take a similar form as one or more of the pluralityof constraints 28. It has been found that these types of formationtechniques not only provide strong constraints and catches, but alsoprovide the small diametric profiles generally required in deliverysystems for implantable devices.

FIGS. 26-31 show additional examples of features for the frame portion210 usable for securing one of the plurality of constraints 28 to theframe portion 210 of the prosthetic valve 16. Consistent with conceptspreviously described, frame portion 1210 can include similar featuresand the constraint 1028 can be similarly secured to the frame portion1210 as desired. As shown in FIG. 26A, one or more of the plurality ofrows of frame members 224 (e.g., the distal row 230 and/or the proximalrow 232 shown in FIG. 12) optionally includes a plurality ofcircumferentially-oriented eyelets 224A. In some examples, the pluralityof circumferentially-oriented eyelets 224A are formed in the proximalrow 232 in the proximal-facing apices 228 at the proximal end 222 of theframe portion 210. Again, these features can additionally oralternatively be located elsewhere in the frame design (e.g., proximatethe distal end 220). Additionally, although the plurality ofcircumferentially-oriented eyelets 224A are shown in each of theproximal-facing apices 226, such an arrangement need not always be thecase (e.g., the circumferentially-oriented eyelets 224A may be in fewerthan all of the proximal-facing apices 226 in a particular row). Variousmethods are usable to form the plurality of circumferentially-orientedeyelets 224A. For example, the plurality of circumferentially-orientedeyelets 224A are optionally formed using a transverse lasing process, atransverse drilling process, a casting process, combinations thereof andother technique as desired.

FIG. 26B shows a plurality of radially-oriented eyelets 224R formed atthe proximal end 222 of the frame portion 210 (e.g., in a commissureattachment region 224P (e.g., commissure post) of the frame portion210). As shown, the radially oriented-eyelets 224R have smoothed edges(e.g., via electro polishing). In some examples, one of the plurality ofconstraints 28 is able to be woven through the radially-oriented eyelets224R to help provide guide the constraint 28 as it extends about theframe portion 210. The radially-oriented eyelets 224R are optionallyformed via lasing, or other manufacturing option as desired.

FIG. 26C shows a frame portion with a plurality of constraint retainers224C (also described as constraint guides) secured to the frame portion210. FIG. 26D shows the prosthetic valve 16 with the constraintretainers 224C and FIG. 26E is a close up view of the constraintretainers 224C as formed with a manufacturing aid Maid. As shown, theprosthetic valve 16 includes one or more constraint retainers 224Cformed as a loop of material coupled to the frame portion 210. In someembodiments, the constraint retainers 224C are each formed by one ormore loops of material, such as polymeric material (e.g., ePTFE fiber),metallic material (e.g., nitinol), or any other material that isbiocompatible and suitable for implantation with the prosthetic valve16. In some examples, the constraint retainers 224C are formed offilamentary material, such as a filament, strand, or a wire (e.g.,polymeric or metallic). The constraint retainers 224C are optionallywound about the frame portion 210 to attach the constraint retainers224C to the frame portion 210.

In some examples, one or more of the constraint retainers 224C areformed of a biocorridible or biodegradable material that biocorrodes orbioabsorbs over time following implantation. Like the afore-mentionedfeatures, the constraint retainers 224C are optionally employed to helpsecure one or more of the plurality of constraints 28 in place and helpprevent slipping off the proximal end the frame portion 210.

FIG. 26E illustrates two of the constraint retainers 224C which havebeen formed by wrapping filaments around the frame members 224 aplurality of times to secure the filaments to the frame members 224 andto form one or more loops suitable for receiving one of the constraints28. As previously described, the filaments forming the constraintretainers 224C can be metallic (e.g., nitinol) polymeric (e.g., ePTFE)or any other biocompatible material. In some examples, the filaments areformed of biocompatible, biocorrodible/biodegradable material such thatthe filaments degrade and are absorbed or pass out of the body after adesired time frame. If desired, the loops of the constraint retainers224C can also be bonded (e.g., in addition or as an alternative to thewrapping securement mechanism) to specific points the frame members 224using a suitable adhesive or other bonding agent, for example.

FIG. 26F illustrates a constraint retainer 224C formed by wrapping afilament around the frame portion 210 at an intersection location, orintersection point, such as intersection location P. The constraintretainer 224C is formed by wrapping a filament around the frame members224 at the intersection P one or more times to secure the filament tothe frame members 224 and to form one or more loops suitable forreceiving one of the constraints 28. As previously described, theconstraint retainer 224C can be metallic (e.g., nitinol) polymeric(e.g., ePTFE) or other material. In some examples, the constraintretainer 225C is formed of biocompatible, biocorrodible/biodegradablematerial such that the constraint retainer 224C degrades and is absorbedor passes out of the body after a desired time frame. If desired, theconstraint retainer 224C can be wrapped and bonded to specific points onthe frame members 224 (e.g., in addition or as an alternative to thewrapping securement mechanism) using a suitable adhesive or otherbonding agent, for example.

In some examples, a method of forming the prosthetic valve 16 with theconstraint retainers 224C includes the following steps:

Obtaining a manufacturing aid Maid for placement through each of theloops of the constraint retainer 224C, where the manufacturing aid Maidshould have a desired diameter to achieve an appropriate level ofinterference of the constraint 28 with the constraint retainer 224C uponremoval of the manufacturing aid Maid, should be able to withstandbonding temperatures for any bonding agent used with the filamentforming the constraint retainer 224C, and should not bond to thematerial forming the constraint retainer 224C, or should otherwise beconfigured such that the manufacturing aid Maid is able to beeffectively removed from the constraint retainer 224C (e.g., a potentialmanufacturing aid Maid may be a PEEK rod);

Wrapping a filament around the frame members 224 one or more times tosecure the filament to the frame members 224 and to form the constraintretainer 224C over the manufacturing aid Maid;

Preparing the frame portion 210, filament, and manufacturing aid Maidfor optional bonding (e.g., by heating in an oven to reflow theadhesive(s) and/or sinter winding(s); and

Removing the manufacturing aid Maid from the constraint retainer 224C.In some examples, the manufacturing aid Maid may be loosened or freedfrom the constraint retainer 224C using a slender rod (or needle) totrace the outer diameters of the manufacturing aid Maid to break themanufacturing aid Maid free from the filament prior to pulling themanufacturing aid Maid out of the constraint retainer 224C (e.g., with atweezers). Generally, the same process may be used to form any number ofconstraint retainers 224C as desired.

Although the constraint retainers 224C are shown at the positioncorresponding to the proximal constraint 180, the constraint retainers224C can be positioned as desired on the frame portion 210, and may beused with any of the plurality of constraints 28 as desired.

FIGS. 25D and 25G illustrate constraint guiding, or constraint retentionfeatures for the prosthetic valve 16 that can be provided in addition toor as an alternative to the rows of apertures 270 and constraintretainers 224C, according to some examples. For example, as shown inFIG. 26D, the prosthetic valve 16 optionally includes a plurality ofconstraint guides 1270, which may operate similarly to the constraintretainers 224C to receive constraints 28 for delivery and deployment ofthe prosthetic valve 16. It should also be understood that anycombination of constraint retention features is employed as desired and,as shown in FIG. 26D, the prosthetic valve 16 also optionally includesone or more constraint retainers 224C formed as loops of materialcoupled to the frame portion 210 (e.g., secured to one or more of theplurality of frame members 224) as previously described.

Like the constraint retainers 224C, the constraint guides 1270 helpretain one or more of the constraints 28 passing around the prostheticvalve 16. The constraint guides 1270 can be described as tunnels,external bands, or belt loops, through which the constraints 28 are ableto be slidably or otherwise received. As shown, the constraint guides1270 are formed by bands or layers of material that define spaces, gaps,or tunnels between layers of material (e.g., between layers of the cover212). The constraints 28 pass through these gaps and are retainedbetween the layers of material. This type of arrangement can becontrasted to those in which constraint 28 is threaded in-and-out of therows of apertures 270, from the interior to the exterior of theprosthetic valve 16. In different terms, as shown in FIG. 26D theconstraint guides 1270 do not result in the constraint 28 passing behindthe cover 212 into the interior of the prosthetic valve 16.

Generally, the approach implemented by the constraint guides 1270 is toembed, or retain one of the constraints 28 within portions of the cover212, rather than having the constraint 28 simply wrapped around theperiphery of the prosthetic valve 16 or laced through an interior andexterior path of the prosthetic valve 16 through the rows of aperture270.

The constraint guides 1270 can provide a variety of desirable features,including one of more of the following: reduced perivalvular leakage dueto elimination of biopsies (e.g., openings or apertures) through thecover 212 of prosthetic valve 16 (e.g., in contrast to some examplesusing the apertures 270); improved durability of the prosthetic valve 16due to less perforations; improved deployment reliability (e.g., releaseand/or tensioning of the constraint 28) due to reduced friction betweenconstraint 28 and the prosthetic valve 16; improved compatibility andreliability of the prosthetic valve 16 due to reduction ofinterference/interaction of vessel walls with the constraint 28; reducedlikelihood of snagging/pinching the constraint 28 as the constraint 28is not captured or otherwise trapped between frame members 224 of theframe portion 210 (e.g., as can happen when the constraint 1272 isthreaded in-and-out of the apertures 270 and/or the frame portion 210);and improved durability of the constraint 28, due to less wear from theframe portion 210 engaging the constraint 28 (e.g., pinching theconstraint 28) when the prosthetic valve 16 is compressed, ordiametrically compacted. These are just a few examples of optionaladvantages according to various embodiments.

Generally, the constraint guides 1270 receive one or more constraints1272 that pass into and out of the constraint guides 1270 in acircumferential path extending around the frame portion 210. The one ormore constraints 28 are thus able to be used for retaining the frameportion 210, and thus the prosthetic valve 16, in a diametricallycompacted, delivery configuration and then permitting the prostheticvalve 16 to be transitioned to a diametrically enlarged, deployedconfiguration upon releasing tension in the one or more constraints 1272using an associated delivery system (such as those previously orsubsequently described).

As shown in FIG. 26D, the prosthetic valve 16 includes a plurality ofrows of the constraint guides 1270, such as a proximal row of constraintguides 1270A, one or more intermediate rows of constraint guides 1270B,and a distal row of constraint guides 1270C. Each of the rows ofconstraint guides 1270 is positioned as desired for a correspondingconstraint 28 to form a loop at a desired level along the prostheticvalve 16. For example, the cover 212 optionally includes a plurality ofseparate constraint guides 1270 each spaced circumferentially apart fromone another about the circumference of the frame portion 210 in a row,with one of the constraints 28 passing through each of the plurality ofconstraint guides 1270 forming a single, circumferentially-aligned row.Although, in some examples, each of a plurality of separate constraintguides 1270 in a row is circumferentially-aligned about thecircumference of the frame portion 210, in other examples a row is notcircumferentially-aligned, but instead is helically aligned, or definesanother path about the circumference of the frame portion 210 and cover212 as desired.

Generally, the proximal row of constraint guides 5270 a slidably receivea proximal constraint 1272 a that is passed through the proximal row ofconstraint guides 5270 a and which can be tensioned to collapse, orradially compress, the prosthetic valve 16 onto a delivery catheter aspreviously described. Similarly, the intermediate constraint guides 5270b and the distal constraint guides 5270 c each slidably receive anintermediate constraint 1272 b and a distal constraint 1272 c,respectively, that are each is passed through the constraint guides 5272and which can be tensioned to collapse, or radially compress, theprosthetic valve 16. As shown, the proximal constraint 1272 a isoptionally passed through constraint retainers 224C associated with theframe portion 210, for example. For reference, a single row may includemultiple constraint guide designs, such as designs consistent withconstraint guide 1270, constraint retainer 224C, or apertures 270.

FIG. 26G is an enlarged view of a portion of the prosthetic valve 16including one of the constraint guides 1270. As shown in FIG. 26G, amanufacturing aid Maid is inserted through the constraint guide 1270.Each of the constraint guides 1270 is optionally formed similarly to theconstraint guide 1270 shown in FIG. 26G. As shown in FIG. 26G, theconstraint guide 1270 includes an outer layer 212A of material and baselayer 212B of material that combine to form a loop and define a tunnel212C, or gap, extending between the outer layer 212A and the base layer212B within a thickness of the cover 212. The tunnel 212C extendsbetween a first opening 212D and a second opening 212E in the outersurface of the cover 212.

As described below, the outer layer 212A and the base layer 212B areoptionally formed as layers of the cover 212, where some methods offorming the constraint guides 1270 include making cut lines Clinethrough the outer layer 212A on either side of the tunnel 212C. In otherembodiments, the outer layer 212A is formed as a discrete flap, or pieceof material that is subsequently secured to the cover 212 to define thetunnel 212C, as well as a portion of the outer surface of the cover 212.

FIG. 26D also illustrates one potential preferred position for thesupport portion of any of the examples herein with regard to aprosthetic valve according to any of the examples herein. In particular,the support portion (e.g., any of support portions 24, 524, 1024, aswell as 3512, 4024, 5024, 6024 subsequently described) is shownpositioned adjacent the frame portion 210 (next to a commissure post orother commissure attachment region 224P) between adjacent leaflets 260of the leaflet construct 214. The location between adjacent leaflets 260is optionally termed a “commissure line,” location. As shown, thesupport portion is pinned, secured, or otherwise maintained by thedelivery catheter at the commissure line adjacent to one of thecommissure attachment regions 224P (e.g., a commissure post) by thedelivery catheter due to the tension on the constraints (whether in thecollapsed, delivery configuration or the expanded, deployedconfiguration).

With additional reference to FIG. 26D, the frame portion 210 generallydefines a circumference extending along a transverse path around thecentral longitudinal axis Xv of the prosthetic valve 16. As previouslyreferenced, the cover 212 is coupled to the frame portion 210 andincludes the constraint guides 1270. In some examples, each constraintguide 1270 defines a tunnel 212C, such as that shown in FIG. 26D, thatextends transversely to the central longitudinal axis Xv of theprosthetic valve 16 between the first opening 212D and second opening212E in the outer surface of the cover 212.

Some methods of forming the prosthetic valve 16 with constraintretainers 224C include one or more of the following steps:

Applying one or more layers of inner cover material to form the baselayer 212B onto a mandrel, where the inner cover material includes anoutwardly-facing adhesive;

Positioning the frame portion 210 over the base layer 212B;

Preparing one or more layers of outer cover material to form the outerlayer 212A, where the outer cover material optionally includes aninwardly facing adhesive;

Cutting the outer layer 212A along the cut lines Cline on either side ofthe tunnel 212C that will be formed at locations corresponding to eachconstraint guide 1270;

Positioning the outer layer 212A over the frame portion 210, the baselayer 212B and the outer layer 212A combining to form the cover 212,where the cut lines Cline, or holes through the outer layer 212A arepositioned at the desired locations for the constraint guides 1270;

Obtaining a manufacturing aid Maid for placement through each of thetunnels 212C (i.e., through the cut lines Cline on either side of thetunnels 212C), where the manufacturing aid Maid should have a desireddiameter to achieve an appropriate level of interference of theconstraint 28 with the constraint guide 1270 upon removal of themanufacturing aid Maid, may have a length corresponding to that ofindividual tunnels 212C or be longer, continuous element for placementthrough multiple tunnels 212C, should be able to withstand bondingtemperatures of the base layer 212B and the outer layer 212A, and shouldnot bond to the base layer 212B and/or outer layer 212A, or shouldotherwise be configured such that the manufacturing aid Maid is able tobe effectively removed from the tunnel 212C (e.g., a potentialmanufacturing aid Maid may be a PEEK rod);

Threading the manufacturing aid Maid through the tunnels 212C betweenthe base layer 212B and the outer layer 212A;

Preparing the frame portion 210, base layer 212B, outer layer 212A, andmanufacturing aid Maid for bonding and bonding one or more of theforegoing (e.g., by overwrapping with a sacrificial compression layerand heating in an oven to reflow the adhesive(s) and/or sinterlayer(s)); and

Removing the manufacturing aid Maid from the tunnel 212C. In someexamples, the manufacturing aid Maid may be loosened or freed from thetunnel 212C by using a slender rod (or needle) to trace the outerdiameter of the manufacturing aid Maid to break the manufacturing aidMaid free from the base layer 212B and/or outer layer 212A prior topulling the manufacturing aid Maid out of the tunnel 212C (e.g., with atweezers). Generally, the same process may be used to form any number ofthe tunnels 212C as desired.

Although some examples have been provided, any of the foregoingconstraint guide features may be used alone or combined into a singleprosthetic valve design as desired.

It should also be understood that various modifications to the featuresof the various frame portions usable for securing one of the pluralityof constraints 28 to the frame portion are contemplated. For exampleFIGS. 26-30 are illustrative of additional features for securing one ofthe plurality of constraints 28 to the frame portion 210. As shown,radially-oriented eyelets can be formed and then transitioned intocircumferentially-oriented eyelets. FIGS. 26-30 are illustrative ofplurality of circumferentially-oriented eyelets 224A formed using such atechnique. FIG. 27 is an isometric view of a proximal part of the frameportion 210, FIG. 28 is a front view of the proximal part of the frameportion 210, FIG. 29 is an end view of the proximal part of the frameportion 210, and FIG. 30 and FIG. 31 illustrate a manner of formation ofone of the plurality of circumferentially-oriented eyelets 224Aaccording to FIGS. 27-31. For example, as shown, the plurality ofcircumferentially-oriented eyelets 224A can optionally be formed byfirst forming a radially-formed eyelet 224R in a radial direction (FIG.30) and then twisting the frame portion 210 (e.g., the distal-facingapices 226) to re-orient the radially-formed eyelet 224Rcircumferentially to define one of the plurality ofcircumferentially-oriented eyelets 224A (FIG. 31). This, twisted formmay be heat set, set by cold working, or set by any of a variety ofmethods as desired depending upon application and material used.

Various advantages may be realized by securing one or more of theplurality of constraints 28 (or the constraint 1028) usingcircumferentially-oriented eyelets 224A, such as the plurality ofcircumferentially-oriented eyelets 224A of any of the foregoingexamples. As one potential advantage, tension forces may be reduced viaa reduction in friction forces that might otherwise be exhibited byfeatures for securing constraints to a prosthetic valve (e.g., byreducing the amount of surface area contacted by a constraint).Moreover, surface profile may be reduced by having the constraint pass“within” the body of the frame 210 and reliability in deployment andcompaction may be increased.

As indicated above, the delivery catheter 14 and delivery catheter 1014can be used with a variety of actuation portions, or actuators. FIGS.31-42 are illustrative of possible features of another actuation portion2020 that may be employed for the delivery catheter 14 or the deliverycatheter 1014 as desired. FIG. 32 is an isometric view of the actuationportion 2020 in an assembled state and FIG. 33 is an isometric view ofthe actuation portion 2020 in a disassembled state, often described asan exploded view. In alternate terms, the actuation portion 2020 canalso be described as a deployment handle or a deployment handleassembly, according to various embodiments.

As shown in FIGS. 31 and 32, the actuation portion 2020 includes ahousing assembly 2100, a rack assembly 2102 (FIG. 33), a drive assembly2104, an actuation assembly 2106, a release assembly 2108, and acatheter subassembly 2110. In general terms, the actuation portion 2020is configured to permit actuation (tensioning and de-tensioning orreleasing) of the plurality of constraints 28 (FIG. 2), release andretraction of the plurality of constraints 28 via retraction of thestake member 30 (FIG. 2) to release the plurality of constraints 28 andretraction of the plurality of constraints 28 from the prosthetic valve16 (FIG. 14A), and can also optionally include a full release of thebody portion 22 of the delivery catheter 14 from the actuation portion2020. In various examples, the actuation portion 2020 is configured toactuate (tension or de-tension the plurality of constraints 28concurrently, all at one time, although separate and/or sequentialactuation (e.g., as described in association with the actuation portion20) is also contemplated.

As shown in FIG. 33, the housing assembly 2100 includes a body portion2200 that extends from a proximal end 2202 to a distal end 2204, definesan outer surface 2206, an inner surface 2208, a proximal section 2210near the proximal end 2202, a distal section 2212 near the distal end2204, a distal clip slot 2214 near the distal end 2204, and a proximalclip slot 2216 near the proximal end 2202, and forms an inner cavity2220 for housing various components of the actuation portion 2020. Asshown, the body portion 2200 is optionally of a clamshell design forease of manufacture and assembly. For example, the body portion 2200 caninclude two halves or longitudinal sections that are able to beassembled together (e.g., using fasteners such as screws), although avariety of configurations are contemplated.

As shown, the proximal section 2210 defines a release assembly track2230 (FIG. 32) formed by a first elongate slot 2232 and a secondelongate slot 2234 formed opposite the first elongate slot 2232 and eachextending longitudinally along the proximal section 2210. Each of thefirst elongate slot 2232 and the second elongate slot 2234 has aproximal enlarged end 2236 and a distal enlarged end 2238. In turn, thedistal section 2212 defines an actuation assembly support 2240 on theouter surface 2206 and an actuation assembly window 2242 in the form ofan opening through the body portion 2200 (e.g., on a lower side of thebody portion 2200).

As shown in FIG. 33, the housing assembly 2100 also optionally includesa knob support 2260 that is coaxially received over the distal section2212 and secured to the body portion 2200 (e.g., using fasteners such asscrews), a proximal lock clip 2262 insertable into the body portion 2200at the proximal end 2202 of the body portion 2200, a distal lock clip2264 insertable into the body portion 2200 at distal end 2204 of thebody portion 2200, and a nose cone 2266 having a clip slot 2268 andwhich is receivable in the distal end 2204 of the body portion 2200.

FIG. 34 is an isometric view of the rack assembly 2102 and FIG. 35 is anenlarged view of the circled portion of FIG. 34, according to someembodiments. As shown, the rack assembly 2102 includes a slide rail 2300and a slider 2302. As shown, the slide rail 2300 extends from a proximalend 2310 to a distal end 2312, forms a stop 2320 at the distal end 2312,and a retraction feature 2322 at the proximal end 2310. The distal end2312 also optionally includes a slot 2324, also described as a pocket,into which the proximal end 30 a of the stake member 30 (FIG. 2) can besecured. The slot 2324 can also be configured to receive and permit theplurality of constraints 28 (FIG. 2) to pass through the slot 2324 asdesired. The slide rail 2300 has an upper track 2330 and a lower track2332 extending between the stop 2320 and the retraction feature 2322,the upper track 2330 and the lower track 2332 being separated by a gap2334.

As shown, the slider 2302 is slidably received between the upper track2330 and the lower track 2332 within the gap 2334 such that the slider2302 can move proximally and distally within the gap 2334. The slider2302 includes a carrier 2338 and a clip 2340 including a plurality ofapertures 2342 configured to receive and secure the plurality ofconstraints 28. The slider 2302, and in particular the carrier 2338,also defines a distal engagement face 2344 for moving the slider 2302proximally and distally within the gap 2334. As shown, the clip 2340 isremovably secured to the carrier 2338 (e.g., using a slip fit, frictionfit, interference fit, or other attachment mechanism).

FIG. 36 is an isometric view of the drive assembly 2104, according tosome embodiments. In some embodiments, the drive assembly 2104 includesa drive member 2400 extending from a proximal end 2402 to a distal end2404, defining a proximal section 2406, a distal section 2408, an outersurface 2410, an inner surface 2412, and an inner lumen 2414 extendingfrom the proximal end 2402 to the distal end 2404. As shown, theproximal section 2406 is slotted longitudinally to define a slot 2416.The outer surface 2410 is threaded, or includes external threads 2418between the proximal end 2402 and the distal end 2404. In someembodiments, the inner lumen 2414 is configured to receive the bodyportion 22 of the delivery catheter 14 such that the body portion 22 ispassable through the drive member 2400. The inner lumen 2414 alsooptionally defines a first diameter through the proximal section 2406and at a location 2430 along the distal section 2408, the distal section2408 defines a reduced diameter, or an engagement feature 2432 (FIG.38).

As shown in FIG. 33, in some embodiments, the actuation assembly 2106includes a deployment knob 2500, a nut portion 2502, a gear portion2504, a spring keeper 2506, a biasing member 2508, and a retainer 2510.

As shown in FIG. 33, the deployment knob 2500 is optionally cylindricaland has an outer surface 2600, an inner surface 2602 (FIG. 38), aproximal end 2604, a distal end 2606, an inner lumen 2608 (FIG. 38)extending from the proximal end 2604 to the distal end 2606, and aplurality of engagement features 2610 which can be seen in FIG. 38(e.g., gear teeth), extending from the inner surface 2602 into the innerlumen 2608 about a circumference of the inner lumen 2608.

In FIG. 33, the nut portion 2502 is shown threaded onto the drive member2400. FIG. 37 shows an isometric view of the nut portion 2502 and thegear portion 2504 in an assembled state with the drive member 2400removed from the nut portion 2502. As shown in FIG. 37, the nut portion2502 has an outer surface 2630, an inner surface 2632 (FIG. 38), aproximal end 2634, a distal end 2636, an inner lumen 2638 (FIG. 38)extending from the proximal end 2634 to the distal end 2636, and aplurality of internal threads 2639 extending from the inner surface 2632into the inner lumen 2638, and a ratchet shoulder 2640 defining aratchet face 2642.

As shown in FIG. 33, and as further described, the gear portion 2504configured to be rotatably received over the nut portion 2502. As shownin FIG. 37, the gear portion 2504 has an outer surface 2660, an innersurface 2662 (FIG. 38), a proximal end 2664, a distal end 2666, an innerlumen 2668 (FIG. 38) extending from the proximal end 2664 to the distalend 2666, and a plurality of engagement features 2669 (e.g., gear teeth)extending from the outer surface 2660, and a ratchet shoulder 2670defining a ratchet face 2672 (FIG. 33) configured to mate with, ormatingly engage with the ratchet face 2642 of the nut portion 2502.

In some embodiments, the biasing member 2508 is optionally one or moresprings (e.g., one or more wave springs) or other biasing means asdesired. The spring keeper 2506 is optionally one or more washers andthe retainer 2510 is optionally one or more spring clips, although avariety of structures may be employed.

FIG. 38 is a longitudinal section of the actuation portion 2020 showingthe actuation assembly 2106 in more detail. As shown, the actuationassembly 2106 is maintained by the housing assembly 2100 with thedeployment knob 2500 rotatably received over the outer surface 2206 andsecured against longitudinal translation. As shown, the knob support2260 is placed at the proximal end 2202 of the body portion 2200 to helpsecure the deployment knob 2500 against longitudinal translation, andprovides a gap 2706 between the outer surface 2206 of the body portion2200 and the inner surface 2602 of the deployment knob 2500 so that theplurality of engagement features 2610 have room to rotate about part ofthe outer surface 2006 of the body portion 2200. As shown, thedeployment knob 2500 is axially offset from the nut portion 2502 and thegear portion 2504. The plurality of engagement features 2610 of thedeployment knob 2500 are exposed to the plurality of engagement features2669 of the nut portion 2502 through the actuation assembly window 2242(FIG. 33), which is formed as an opening through the body portion 2200on the lower side of the body portion 2200. Thus, rotation of thedeployment knob 2500 causes the engagement features 2610 to mesh withthe engagement features 2669 resulting in positive or negative angularrotation of the gear portion 2504.

As shown in FIG. 38, the gear portion 2504 and the nut portion 2502 arerotatably received by the housing assembly 2100 with the nut portion2502 secured against longitudinal translation by the housing assembly2100. The gear portion 2504 is slidably and rotatably received over thenut portion 2502 and is permitted a limited amount of longitudinaltravel by the housing assembly 2100. The gear portion 2504 is secured tothe body portion 2200 of the housing assembly 2100 with the springkeeper 2506 and the retainer 2510 holding the biasing member 2508against the gear portion 2504 to bias the gear portion 2504 distally. Inthis manner, the gear portion 2504 can be displaced a limited amount inthe proximal direction once the biasing force (e.g., spring constant) ofthe biasing member 2508 is overcome. So biased, the ratchet face 2672engages with the ratchet face 2642 of the nut portion 2502 (FIG. 37) sothat rotation the gear portion 2504 results in rotation of the nutportion 2502 until a torsional limit is exceeded such that the biasingforce is overcome, and the ratchet face 2672 and the ratchet face 2642slip, or ratchet over one another. In this manner, the actuationassembly 2106 defines a clutch, and more specifically a ratchet or slipclutch, although other clutch mechanisms (e.g., magnetic) are alsocontemplated and are suitable for use.

According to the foregoing description, rotation of the deployment knob2500 results in positive or negative angular rotation of the nut portion2502 with a clutch mechanism defined between the deployment knob 2500and the nut portion 2502 once sufficient resistance to rotation of thenut portion 2502 is encountered. As will be subsequently described,rotation of the nut portion 2502 (and thus rotation of the deploymentknob 2500) is used to drive the drive assembly 2104, and morespecifically to longitudinally translate the drive member 2400 inproximal and distal directions within the housing assembly 2100.

FIG. 39 is an isometric view of the release assembly 2108, according tosome embodiments. As shown in FIG. 39, in some embodiments, the releaseassembly 2108 includes a lock flexure 2700, a first button 2702, and asecond button 2704. In some embodiments, the lock flexure 2700 includesa first flex arm 2710 and a second flex arm 2712. Each of the first flexarm 2710 and the second flex arm 2712 includes a grasping portion 2720configured to engage and grasp the retraction feature 2322 at theproximal end 2310 of the slide rail 2300 (FIG. 34) upon inward flexingof the first flex arm 2710 and the second flex arm 2712. The firstbutton 2702 and the second button 2704 are secured to the first flex arm2710 and the second flex arm 2712 and such that the first button 2702and the second button 2704 are able to be depressed to inwardly flex thefirst flex arm 2710 and the second flex arm 2712. In some examples, therelease assembly 2108 includes a first stop feature 2730 formed on thefirst button 2702 and a similar, second stop feature (not shown) formedon the second button 2704. Each of the first stop feature 2730 and thesecond stop feature is optionally configured to help prevent inadvertentlongitudinal retraction of the slide rail 2300 (FIG. 34) in the proximaldirection. The release assembly 2108 also optionally includes a firstlocking feature 2740 (e.g., a channel) and a second locking feature 2742(e.g., a channel) formed by the first button 2702 and the second button2704 such that the release assembly 2108 is secured longitudinally tothe housing assembly 2100 until the first button 2702 and the secondbutton 2704 are depressed.

A shown in FIG. 33, in some embodiments, the catheter subassembly 2110is coupled to the body portion 22 (FIG. 2) of the delivery catheter 14(FIG. 2). For example, the catheter subassembly 2110 optionally includesa tube extension 2800 (e.g., for receiving a guidewire that can passthrough the actuation portion 2020 to the body portion 22 of thedelivery catheter 14), a proximal coupling 2802 and a distal coupling2804. The distal coupling 2804 is optionally secured to the connectorhub 46 of the body portion 22 and the proximal coupling 2802 isoptionally secured to a portion of the housing assembly 2100, asdescribed in further detail below. In some examples, the proximalcoupling 2802 includes a clip slot 2806 Generally, the plurality ofconstraints 28 and the stake member 30 (FIG. 2) are permitted to bypassthe catheter subassembly 2110 to be secured to the rack assembly 2102,as described in further detail below.

Some methods of assembling the actuation portion 2020 include assemblingthe catheter subassembly 2110 to the body portion 22 of the deliverycatheter 14 by securing the distal coupling 2804 to the connector hub 46of the body portion 22. The nose cone 2266 is received over the bodyportion 22 (e.g., coaxially received over the body portion 22) of thedelivery catheter 14 such that the connector hub 46 and/or distalcoupling 2804 are engaged with (e.g., received within) and abuttedagainst the nose cone 2266. The tube extension 2800 of the cathetersubassembly 2110 is received within the slide rail 2300 and the slider2302 (FIG. 34) of the rack assembly 2102 (e.g., coaxially receivedwithin the slide rail 2300 and the slider 2302) such that the slide rail2300 and the slider 2302 are slidable longitudinally over the tubeextension 2800 (e.g., being slidable along the tube extension 2800between the proximal coupling 2802 and the distal coupling 2804).

The drive assembly 2104, and in particular the drive member 2400 isslidably received over the rack assembly 2102 (e.g., coaxially receivedover the rack assembly 2102). FIG. 38 shows a portion of thisinteraction between the drive assembly 2104 and the rack assembly 2102,wherein the drive member 2400 is slidable over the slide rail 2300 andalong the slide rail 2300 until the distal engagement face 2344 of theslider 2302 is proximally engaged by the engagement feature 2432 formedinside of the drive member 2400. Once the drive member 2400 is movedproximally sufficiently such that the engagement feature 2432 engagesthe distal engagement face 2344 (FIG. 34) of the slider 2302, then theslider 2302 is moved proximally, or is longitudinally translated in aproximal direction, within the slide rail 2300 as the drive member 2400slides over the slide rail 2300. This interaction will be described ingreater detail with respect to FIGS. 40-43, which are illustrative ofoperation of the actuation portion 2020, according to some examples.

As indicated by FIG. 38, the nut portion 2502 of the actuation assembly2106 is threaded onto the drive member 2400 with the internal threads2639 engaged with the external threads 2418. As previously described,the gear portion 2504 is slidably and rotatably received over the nutportion 2502 and engaged in clutch arrangement such that rotation of thegear portion 2504 results in rotation of the nut portion 2502 up until atorsional limit is reached at which point the gear portion 2504 isallowed to slip against the nut portion 2502. Although a clutcharrangement is defined by the nut portion 2502 and the gear portion 2504according to various examples, it should also be understood the two cansimply be rotationally fixed together (e.g., being formed integrallywith one another or simply by being separate, but fixedly connectedparts).

As previously described, the actuation assembly 2106 is maintained bythe housing assembly 2100 with the deployment knob 2500 rotatablyreceived over the outer surface 2206 of the body portion 2200 andsecured against longitudinal translation. The knob support 2260 islocated at the proximal end 2604 of the deployment knob 2500 to helpsecure the deployment knob 2500 against longitudinal translation, andalso to provide a gap 2706 between the outer surface 2206 of the bodyportion 2200 and the inner surface 2602 of the deployment knob 2500 inwhich the engagement features 2610 have room to rotate. The plurality ofengagement features 2610 of the deployment knob 2500 are exposed to theplurality of engagement features 2669 of the nut portion 2502 throughthe actuation assembly window 2242 such that rotation of the deploymentknob 2500 causes the engagement features 2610 to mesh with theengagement features 2669 resulting in positive or negative angularrotation of the gear portion 2504, which translates to longitudinaltranslation (proximal or distal, depending upon the direction ofrotation of the deployment knob 2500) of the drive member 2400.

As understood with reference to FIG. 33, the lock flexure 2700 isconfigured to be slidably received in the release assembly track 2230(FIG. 32) such that the first button 2702 and the second button 2704 arereceived in the distal enlarged ends 2238 of each of the first elongateslot 2232 and the second elongate slot 2234. The distal enlarged ends2238 engage with the first button 2702 and the second button 2704 to“lock” the release assembly 2108 to the housing assembly 2100. When thefirst button 2702 and the second button 2704 are depressed to flex thefirst flex arm 2710 and the second flex arm 2712 (FIG. 39) inwardly, thefirst locking feature 2740 and the second locking feature 2742 (FIG. 39)move inwardly and accept the edges of the first elongate slot 2232 andthe second elongate slot 2234. This “unlocks” the release assembly 2108and permits the first button 2702 and the second button 2704, and thusthe lock flexure 2700 to be slide proximally out of the distal enlargedends 2238 of each of the first elongate slot 2232 and the secondelongate slot 2234 and proximally along the release assembly track 2230.

FIG. 40 is an enlarged view of the distal coupling 2804 of the cathetersubassembly 2110 secured to the connector hub 46 of the body portion 22of the delivery catheter 14 (FIG. 2) juxtaposed with the distal end 2312of the slide rail 2300. The distal end 2312 of the slide rail 2300receives abuts against the distal coupling 2804 and/or connector hub 46to stop distal movement of the slide rail 2300 (unless purposefullyreleased to be removed from the housing assembly 2100, as describedbelow). The distal end 2312 of the slide rail 2300, and in particularthe slot 2324 receives and secures the proximal end 30 a of the stakemember 30 to the slide rail 2300. Though not shown in FIG. 40, the slot2324 also permits the plurality of constraints 28 to pass from theconnector hub 46 of the body portion 22 through the slot 2324 to beattached to the clip 2340 of the slider 2302, and in particular to besecured in the plurality of apertures 2342 of the clip 2340 (FIG. 34).

FIGS. 40-42 are longitudinal cross sections of the actuation portion2020 at various stages of operation, according to some embodiments. Asshown in FIG. 41, the nose cone 2266 is received over the connector hub46, inserted into the distal end 2204 of the body portion 2200 of thehousing assembly 2100, and the nose cone 2266 and the connector hub 46are secured to the body portion 2200 using the distal lock clip 2264which passes through the distal clip slot 2214 (FIG. 33) in the bodyportion 2200, the clip slot 2268 in the nose cone 2266 (FIG. 33), andover a clip slot 2808 (FIG. 40) in the connector hub 46 to secure theconnector hub 46 and the nose cone 2266 to the housing assembly 2100. Inturn, the proximal lock clip 2262 is received through the proximal clipslot 2216 (FIG. 33) in the body portion 2200 and over the clip slot 2806in the proximal coupling 2802 of the catheter subassembly 2110 to securethe proximal coupling 2802, and thus the catheter subassembly 22110 tothe housing assembly 2100.

Some examples of methods for operating the actuation portion 2020 aredescribed below with reference to FIGS. 40-43. As shown in FIG. 41, thedeployment knob 2500 has been rotated such that the drive member 2400has been moved proximally to move the slider 2302 proximally, pullingthe plurality of constraints 28 (FIG. 2) proximally. As shown in FIG.14A, by pulling the plurality of constraints 28 proximally, the proximalconstraining loop 195, the distal constraining loop 196, and theintermediate constraining loop 197 constrict about the prosthetic valve16 to transition the valve to the compacted delivery state. Theprosthetic valve 16 can then be retracted into the sheath 12 forintraluminal delivery to a desired treatment site, or location.

The prosthetic valve 16 (or other implantable device) can be extendedfrom the sheath 12 and the deployment knob 2500 can be derotated, orrotated in the reverse direction to de-tension, or remove tension, onthe plurality of constraints 28 with the drive member 2400 movingdistally to the position shown in FIG. 42. In some examples, a bias ofthe prosthetic valve 16 to an expanded state causes provides a distaltension on the plurality of constraints 28, causing the slider 2302 tomove distally with the drive member 2400 as previously described.

With the tension on the constraints 28 by the actuation portion 2020reduced, or removed a release operation can be performed to transitionthe release assembly 2108 to the position shown in FIG. 43. Inparticular, the first button 2702 and the second button 2704 (FIG. 33)are depressed causing the first locking feature 2740 and the secondlocking feature 2742 (FIG. 39) to move into position to permit proximalmovement of the lock flexure 2700. At the same time, the first flex arm2710 and the second flex arm 2712 (FIG. 39) are flexed inwardly suchthat the grasping portions 2720 of each of the first flex arm 2710 andthe second flex arm 2712 engage and grasp the retraction feature 2322 atthe proximal end 2310 of the slide rail 2300. With the first lockingfeature 2740 and the second locking feature 2742 engaged with the edgesof the release assembly track 2230, the release assembly 2108 is lockedin an inwardly deflected position and thus locked to the slide rail 2300by the grasping portions 2720. The release assembly 2108 is then slideproximally in the release assembly track 2230, pulling the slide rail2300 proximally within the housing assembly 2100.

As the slide rail 2300 is pulled proximally, the proximal end 30 a ofthe stake member 30 (FIG. 2) is retracted proximally and the distalconstraining loop 196, the intermediate constraining loop 197, and theproximal constraining loop 195, and in particular the respective catches192, 194, 190, are released from the stake member 30. Once the sliderail 2300 has been sufficiently retracted, the stop 2320 at the distalend 2312 of the slide rail 2300 engages the slider 2302 and beginsretracting the slider 2302 proximally with the slide rail 2300. At thispoint, the plurality of constraints 28, now free from the stake member30, retract from around the prosthetic valve 16, freeing the prostheticvalve (or other implantable device) from the delivery catheter 14 (e.g.,at a desired delivery site).

FIG. 44 is illustrative of still another operational method for theactuation portion 2020. For example, in the instance that a user (notshown) wishes to bypass the functionality of the actuation portion 2020,the user may remove the distal lock clip 2264 and the proximal lock clip2262 from the housing assembly 2100 freeing the nose cone 2266, theconnector hub 46, and the catheter subassembly 2110 from the housingassembly 2100. The deployment knob 2500 may then be rotated in thedirection causing the drive member 2400 to move distally until the drivemember 2400 is driven distally out of the nut portion 2502 (FIG. 38) andthus released from the actuation assembly 2106. The rack assembly 2102and the drive assembly 2104 can then be pulled distally from the housingassembly 2100, along with the body portion 22 of the delivery catheter14 (FIG. 2). The user may then directly access the plurality ofconstraints 28 and the stake member 30 (FIG. 2) as desired for manualmanipulation. This may be desirable if delivery issues are encounteredor that the user wishes to undertake other diagnostic or remedialmeasures. As previously stated, the foregoing actuation portion 2020 andassociated methods is interchangeably usable with the delivery catheter1014, including use with different implantable devices (e.g., stentgrafts) as desired.

FIGS. 45 to 47 schematically illustrate various additional, optionalpositions of guides (e.g., proximal, distal, and/or intermediate guides)relative to various leaflet construct positions of prosthetic valvesaccording to various examples. For reference, only frames are shown ofthe illustrative prosthetic valves for ease of visualization. For theseadditional examples, it should be understood that any of the leafletconstructs previously described (and associated prosthetic valves) maybe positioned relative to the various guide locations in a similarmanner to those locations shown in FIGS. 45 to 47.

FIG. 45 is a side view of another transcatheter delivery system 4010, inaccordance with an embodiment. The delivery catheter 4014 includes abody portion 4022, a support portion 4024, a tip portion 4026, and aplurality of constraints (not shown). As shown, the implantable device4016 may be a prosthetic valve including a leaflet construct (not shown)located inside, and supported by the support portion 4024 within thebounds of a leaflet region 4018. In some embodiments, the leaflet region4018 is positioned along the support portion 4024 between the proximalguide 4082 and the distal guide 4084. For example, in some embodiments,the leaflet region 4018 does not extend longitudinally beyond theproximal guide 4082 and the distal guide 4084. In some embodiments, theleaflet region 4018 can be located between the intermediate guide 4086and the proximal guide 4082, which may reduce or eliminate volume of theguide(s) in the leaflet region 4018 when the implantable device 4016 iscompacted into the delivery state onto the support portion 4024.

FIG. 46 is a side view of another transcatheter delivery system 5010, inaccordance with an embodiment. The delivery catheter 5014 includes abody portion 5022, a support portion 5024, a tip portion 5026, and aplurality of constraints (not shown). As shown, the support portion 5024is generally configured to be received in an implantable device 5016 andto support the implantable device 5016 through delivery to, anddeployment at a desired treatment location in a body of a patient (notshown). As shown, the support portion 5024 includes a shaft 5080, aproximal guide 5082, a first intermediate guide 5086, a secondintermediate guide 5088, and a distal guide 5084.

As shown, the implantable device 5016 may be a prosthetic valveincluding a leaflet construct (not shown) located inside, and supportedby the support portion 4024 within the bounds of in a leaflet region5018. In some embodiments, the leaflet region 5018 is positioned on thesupport portion 5024 between the proximal guide 5082 and the secondintermediate guide 5088. For example, in some embodiments, the leafletregion 5018 is positioned over the first intermediate guide 5086. Insome embodiments, the first intermediate guide 5086 is generally smallerthan the proximal guide 5082 and the second intermediate guide 5088 sothat the volume of the first intermediate guide 5086 in the leafletregion 5018 is reduced when the implantable device 4016 is compactedinto the delivery state onto the support portion 5024.

FIG. 47 is a side view of another transcatheter delivery system 6010, inaccordance with an embodiment. The delivery catheter 6014 includes abody portion 6022, a support portion 6024, a tip portion 6026, and aplurality of constraints (not shown). As shown, the support portion 6024is generally configured to be received in an implantable device 6016 andto support the implantable device 6016 through delivery to, anddeployment at a desired treatment location in a body of a patient (notshown). As shown, the support portion 6024 includes a shaft 6080, aproximal guide 6082, an intermediate guide (not shown), and a distalguide (not shown).

As shown, the implantable device 6016 may include a frame portion and avalve including a leaflet construct (not shown) supported by the supportportion 6024 at a position within the support portion 6024 correspondingto the boundaries of a leaflet region 6018. In some embodiments, theleaflet region 6018 is positioned on the support portion 6024 betweenthe proximal guide 6082 and the distal guide 6084. For example, in someembodiments, the leaflet region 6018 does not extend longitudinallybeyond the proximal guide 6082 and the distal guide 6084. In someembodiments, the leaflet region 6018 can be located between theintermediate guide 6086 and the proximal guide 6082, which may reduce oreliminate volume of the guide(s) in the leaflet region 6018. As shown,the implantable device 6016 may include a plurality of posts andthru-hole features (e.g., such as those of FIGS. 25A, 25B and 26 to 30)which may help permit movement of the proximal guide 6082 out of theleaflet region 6018 when the implantable device 4016 is compacted intothe delivery state onto the support portion 6024.

FIG. 48 shows an enhanced flexibility portion 7080 of shaft 80 (FIG. 4),in accordance with various embodiments, which may be implemented for anyof the other shafts previously described as well. As previouslyreferenced, shaft 80 is formed as a hollow tube (e.g., hypotube), forexample using nitinol, stainless steel, or other metallic or polymericmaterials. In various examples, the shaft 80 is configured to receive aguidewire (not shown) for guiding the delivery catheter in which theshaft 80 is assembled to a desired treatment location. If desired, aliner (not shown) of a polymeric or other low friction material may beincorporated into the shaft 80 to reduce wear or interference with aguidewire (not shown) received within the shaft 80.

In some examples, the enhanced flexibility portion 7080 includes a cutpattern formed through the wall of the shaft 80 (e.g., laser cut).Although the pattern is described as being a “cut” pattern, anyformation technique (e.g., etching) can be used to form the “cut”pattern. In the example of FIG. 48, the cut pattern is a broken, spiralpattern that leaves continuous longitudinal sections 7082 of the shaft80. In different terms, the cut pattern includes intermittent, helicalcuts that are staggered along the longitudinal length of the enhancedflexibility portion 7080. The cuts, or turns, define a period, or pitchP between adjacent cut lines in each of the proximal section 7080P anddistal section 7080D of the enhanced flexibility portion 7080. As shownin FIG. 48, the pitch P may vary along the length of the enhancedflexibility portion 7080. For example, the pitch P of the spiral cutpattern may be greater in a proximal section 7080P, then smaller at adistal section 7080D. If desired the pitch may increase again at the endof the distal section 7080D to provide another transition to acontinuous, or uncut portion at or adjacent the distal section 42 of thebody portion 22 (FIG. 4).

In terms of where the enhanced flexibility portion 7080 begins and endsalong the length of the shaft 80, that portion 7080 could form anentirety of the length of the shaft 80. However, in various examples,the enhanced flexibility portion 7080 begins at a location at or nearthe distal section 42 of the body portion 22. In one example, theenhanced flexibility portion extends for 11 cm in total length andinitiates approximately 2 mm proximal to distal section 42 of the bodyportion 22, for example. In terms of pitch P, in one example the distalsection 7080D has a pitch of 0.008 inches, with and an intermittent cutpattern of 3.5 cuts per revolution. In terms of the proximal portion7080P, in one example, the pitch P transitions from pitch from 0.008inches in the distal section 7080D to 0.016 inches in the proximalsection 7080P with 3.5 cuts per revolution over 25 mm.

In another example, enhanced flexibility portion extends for 25 cm(e.g., beginning in a similar location to that described above) with aninitial transition in the distal section 7080D extending for 25 mm at apitch P changing from 0.016 inches to 0.008 inches with 3.5 cuts perrotation, then extending through the distal section 7080P for 150 mm ata pitch P of 0.008 inches with 3.5 cuts per rotation, and then for 25 mmat a pitch P changing from 0.008 inches to 0.016 inches with 3.5 cutsper rotation. Still another example includes an initial transitionportion in the distal section 7080P extending for 25 mm at a pitch Pchanging from 0.016 inches to 0.008 inches with 3.5 cuts per rotation,then extending for 150 mm at a pitch P of 0.008 inches with 3.5 cuts perrotation, and then the proximal portion 7080P extending for 25 mm at apitch changing from 0.008 inches to 0.016 inches with 3.5 cuts perrotation.

Though some specific examples of cut pattern dimensions are provided, itshould be understood that these dimensions are provided for illustrativepurposes, and should not be read as limiting design to a particularlength, starting point, or ending point for the enhanced flexibilityportion 7080. The foregoing dimensions are provided as examples forillustrative purposes, and though each of the foregoing dimensions, anycombination of those dimensions, and any range between and includingthose dimensions are within the scope of inventive concepts describedherein, additional dimensions are contemplated and are not outside thescope of such concepts.

In some examples, the shaft 7080 may include a liner (not shown) of adesired material (e.g., polyimide or fluoropolymer) lining the insidesurface of the shaft 7080. In other examples, the shaft 7080 may becharacterized by an absence of any liner and be continuously formed as amonolithic unit (e.g., entirely of a hypotube). The spiral cut patternof FIG. 48 can be particularly advantageous in this respect, as theabrasion or other wear on a guidewire received within the shaft 7080 isnot present with use of the spiral cut patterns disclosed herein.

Leaflet Materials

The leaflet constructs of the various embodiments may be formed of abiocompatible, synthetic material (e.g., including ePTFE and ePTFEcomposites, or other materials as desired). Other biocompatible polymerswhich can be suitable for use in synthetic leaflets include but are notlimited to the groups of urethanes, silicones (organopolysiloxanes),copolymers of silicon-urethane, styrene/isobutylene copolymers,polyisobutylene, polyethylene-co-poly(vinyl acetate), polyestercopolymers, nylon copolymers, fluorinated hydrocarbon polymers andcopolymers or mixtures of each of the foregoing.

In other examples, such leaflet constructs may be formed of a naturalmaterial, such as repurposed tissue, including bovine tissue, porcinetissue, or the like.

As used herein, the term “elastomer” refers to a polymer or a mixture ofpolymers that has the ability to be stretched to at least 1.3 times itsoriginal length and to retract rapidly to approximately its originallength when released. The term “elastomeric material” refers to apolymer or a mixture of polymers that displays stretch and recoveryproperties similar to an elastomer, although not necessarily to the samedegree of stretch and/or recovery. The term “non-elastomeric material”refers to a polymer or a mixture of polymers that displays stretch andrecovery properties not similar to either an elastomer or elastomericmaterial, that is, considered not an elastomer or elastomeric material.

In accordance with some embodiments herein, the leaflet constructcomprises a composite material having at least one porous syntheticpolymer membrane layer having a plurality of pores and/or spaces and anelastomer and/or an elastomeric material and/or a non-elastomericmaterial filling the pores and/or spaces of the at least one syntheticpolymer membrane layer. In accordance with other examples, the leafletconstruct further comprises a layer of an elastomer and/or anelastomeric material and/or a non-elastomeric material on the compositematerial. In accordance with some examples, the composite materialcomprises porous synthetic polymer membrane by weight in a range ofabout 10% to 90%

An example of a porous synthetic polymer membrane includes expandedfluoropolymer membrane having a node and fibril structure defining thepores and/or spaces. In some examples, the expanded fluoropolymermembrane is expanded polytetrafluoroethylene (ePTFE) membrane. Anotherexample of porous synthetic polymer membrane includes microporouspolyethylene membrane.

Examples of an elastomer and/or an elastomeric material and/or anon-elastomeric material include, but are not limited to, copolymers oftetrafluoroethylene and perfluorom ethyl vinyl ether (TFE/PMVEcopolymer), (per)fluoroalkylvinylethers (PAVE), urethanes, silicones(organopolysiloxanes), copolymers of silicon-urethane,styrene/isobutylene copolymers, polyisobutylene,polyethylene-co-poly(vinyl acetate), polyester copolymers, nyloncopolymers, fluorinated hydrocarbon polymers and copolymers or mixturesof each of the foregoing. In some examples, the TFE/PMVE copolymer is anelastomer comprising essentially of between 60 and 20 weight percenttetrafluoroethylene and respectively between 40 and 80 weight percentperfluoromethyl vinyl ether. In some examples, the TFE/PMVE copolymer isan elastomeric material comprising essentially of between 67 and 61weight percent tetrafluoroethylene and respectively between 33 and 39weight percent perfluoromethyl vinyl ether. In some examples, theTFE/PMVE copolymer is a non-elastomeric material comprising essentiallyof between 73 and 68 weight percent tetrafluoroethylene and respectivelybetween 27 and 32 weight percent perfluorom ethyl vinyl ether. The TFEand PMVE components of the TFE-PMVE copolymer are presented in wt %. Forreference, the wt % of PMVE of 40, 33-39, and 27-32 corresponds to a mol% of 29, 23-28, and 18-22, respectively.

In some examples, the TFE-PMVE copolymer exhibits elastomer,elastomeric, and/or non-elastomeric properties.

In some examples, the composite material further comprises a layer orcoating of TFE-PMVE copolymer comprising from about 73 to about 68weight percent tetrafluoroethylene and respectively from about 27 toabout 32 weight percent perfluorom ethyl vinyl ether.

In some examples, the leaflet construct is an expandedpolytetrafluoroethylene (ePTFE) membrane having been imbibed withTFE-PMVE copolymer comprising from about 60 to about 20 weight percenttetrafluoroethylene and respectively from about 40 to about 80 weightpercent perfluoromethyl vinyl ether, the leaflet construct furtherincluding a coating of TFE-PMVE copolymer comprising from about 73 toabout 68 weight percent tetrafluoroethylene and respectively about 27 toabout 32 weight percent perfluoromethyl vinyl ether on theblood-contacting surfaces.

As discussed above, the elastomer and/or an elastomeric material and/ora non-elastomeric material may be combined with the expandedfluoropolymer membrane such that the elastomer and/or the elastomericmaterial and/or the non-elastomeric material occupies substantially allof the void space or pores within the expanded fluoropolymer membrane.

In accordance with an embodiment, the composite material can include anexpanded fluoropolymer material made from porous ePTFE membrane, forinstance as generally described in U.S. Pat. No. 7,306,729 to Bacino.

The expanded fluoropolymer membrane, used to form some of the compositesdescribed, can comprise PTFE homopolymer. In alternative embodiments,blends of PTFE, expandable modified PTFE and/or expanded copolymers ofPTFE can be used. Non-limiting examples of suitable fluoropolymermaterials are described in, for example, U.S. Pat. No. 5,708,044, toBranca, U.S. Pat. No. 6,541,589, to Baillie, U.S. Pat. No. 7,531,611, toSabol et al., U.S. patent application Ser. No. 11/906,877, to Ford, andU.S. patent application Ser. No. 12/410,050, to Xu et al.

Frame Materials

The various frames can be etched, cut, laser cut, stamped,three-dimensional printed or wire wound, among other suitable processes.The frames can be self-expanding or balloon expandable (e.g., whenconfigured for transcatheter implantation) or non-expandable (e.g., whenconfigured for surgical implantation). The various frames can comprisematerials, such as, but not limited to, any metallic or polymericmaterial, such as an elastically (e.g., nitinol) or plastically (e.g.,stainless steel) deformable metallic or polymeric material that isgenerally biocompatible. Other materials suitable for any of the framesdescribed herein include, but are not limited to, other titanium alloys,stainless steel, cobalt-nickel alloy, polypropylene, acetyl homopolymer,acetyl copolymer, a drawn filled tube (e.g., nitinol wire with aplatinum core), other alloys or polymers, or any other material that isgenerally biocompatible having adequate physical and mechanicalproperties to function as a frame as described herein.

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatus configured to perform the intended functions. It should alsobe noted that the accompanying drawing figures referred to herein arenot necessarily drawn to scale, but may be exaggerated to illustratevarious aspects of the present disclosure, and in that regard, thedrawing figures should not be construed as limiting.

Inventive concepts have been described above both generically and withregard to specific embodiments. It will be apparent to those skilled inthe art that various modifications and variations can be made in theembodiments without departing from the scope of the disclosure. Thus, itis intended that the disclosure is inclusive of modifications andvariations provided they come within the scope of the appended claims.

What is claimed is:
 1. A transcatheter delivery system including an actuation assembly for a delivery catheter, the actuation assembly being configured to tension and de-tension one or more device constraints, the actuation assembly comprising: a body portion; a constraint guide coupled to the body portion; at least one constraint maintained by the constraint guide; a stake member, the at least one constraint releasably secured to the stake member; a housing assembly coupled to the body portion; a rack assembly received in the housing assembly and including a slide rail secured to the stake member and slidably receiving a slider secured to the at least one constraint; a drive assembly slidably received over the slide rail and engageable with the slider to longitudinally translate the slider within the slide rail; and an actuation assembly including a rotatable deployment knob and configured to longitudinally translate the drive assembly along the slide rail.
 2. The transcatheter delivery system of claim 1, wherein the actuation portion further comprises a release assembly configured to longitudinally translate the slide rail to longitudinally translate the stake member.
 3. The transcatheter delivery system of claim 1, wherein the at least one constraint includes a catch releasably secured to the stake member.
 4. A transcatheter delivery system including a delivery catheter, the delivery catheter comprising: a body portion, a support portion extending from the body portion, the support portion configured to support an implantable device; a stake member; at least one constraint configured to be tensioned to the stake member to maintain the implantable device in a compacted delivery configuration, to be de-tensioned from the stake member to permit the implantable device to be transitioned to an expanded deployed configuration, and to be released from the stake member to release the implantable device from the delivery catheter; and an actuation portion configured to tension the at least one constraint, to de-tension the at least one constraint, and to release the at least one constraint from the stake member, the actuation portion including, a housing assembly coupled to the body portion, a rack assembly received in the housing assembly and including a slide rail secured to the stake member and slidably receiving a slider secured to the at least one constraint, a drive assembly slidably received over the slide rail and engageable with the slider to longitudinally translate the slider within the slide rail, and an actuation assembly including a rotatable deployment knob and configured to longitudinally translate the drive assembly along the slide rail.
 5. The transcatheter delivery system of claim 4, wherein the actuation portion further comprises a release assembly configured to longitudinally translate the slide rail to longitudinally translate the stake member.
 6. The transcatheter delivery system of claim 5, wherein the at least one constraint includes a catch releasably secured to the stake member.
 7. The transcatheter delivery system of claim 4, wherein the drive assembly includes a clutch.
 8. The transcatheter delivery system of claim 7, wherein the clutch is a ratchet clutch.
 9. The transcatheter delivery system of claim 4, wherein the body portion, the rack assembly, and the drive assembly are releasably secured to the housing assembly by one or more clips, such that the rack assembly and the drive assembly are configured to be released from the drive assembly and the housing and slid longitudinally out from a distal end of the housing assembly.
 10. The transcatheter delivery system of claim 4, further comprising an implantable device maintained in a compacted delivery configuration on the support portion by the at least one constraint.
 11. The transcatheter delivery system of claim 10, wherein the implantable device is a prosthetic valve.
 12. The transcatheter delivery system of claim 14, wherein the delivery catheter includes at least two constraints, each constraint configured to be tensioned to the stake member to maintain the implantable device in the compacted delivery configuration, de-tensioned from the stake member to permit the implantable device to be transitioned to the expanded deployed configuration, and to be released from the stake member to release the implantable device from the delivery catheter.
 13. The transcatheter delivery system of claim 14, wherein the actuation assembly further includes a nut portion and a gear portion defining a clutch arrangement such that rotation of the gear portion results in rotation of the nut portion up until a torsional limit is reached at which point the gear portion is allowed to slip against the nut portion.
 14. The transcatheter delivery system of claim 13, wherein the nut portion is threaded onto the drive assembly.
 15. The transcatheter delivery system of claim 13, wherein the gear portion includes a plurality of teeth engaged with a plurality of teeth of the deployment knob.
 16. The transcatheter delivery system of claim 14, further comprising a shaft extending through the body portion and the support portion, the shaft including an enhanced flexibility portion proximal to the support portion, the enhanced flexibility portion including a distal section having a cut pattern characterized by a first pitch and a proximal section having a cut pattern characterized by a second pitch that is greater than the first pitch.
 17. The transcatheter delivery system of claim 16, wherein the distal section includes a distal transition portion having cut pattern characterized by a third pitch that is greater than the first pitch.
 18. A transcatheter delivery system including an actuation assembly for a delivery catheter, the actuation assembly being configured to tension and de-tension one or more device constraints, the actuation assembly comprising: a body portion; a constraint guide coupled to the body portion; at least one constraint maintained by the constraint guide; a stake member, the at least one constraint releasably secured to the stake member; a housing assembly coupled to the body portion; a rack assembly received in the housing assembly and including a slide rail secured to the stake member and slidably receiving a slider secured to the at least one constraint; a drive assembly slidably received over the slide rail and engageable with the slider to longitudinally translate the slider within the slide rail, the drive assembly including a clutch; and an actuation assembly including a rotatable deployment knob and configured to longitudinally translate the drive assembly along the slide rail.
 19. The transcatheter delivery system of claim 18, wherein the clutch is a ratchet clutch.
 20. The transcatheter delivery system of claim 18, wherein the actuation assembly further includes a nut portion and a gear portion defining a clutch arrangement such that rotation of the gear portion results in rotation of the nut portion up until a torsional limit is reached at which point the gear portion is allowed to slip against the nut portion. 